Pure Global

NuVasive TLX Interbody System - HSA Registration DE0507980

Access comprehensive regulatory information for NuVasive TLX Interbody System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507980 and owned by Nuvasive Inc. The device was registered on April 10, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0507980
NuVasive TLX Interbody System
HSA Registration Number: DE0507980
Pure Global
DJ Fang

DJ Fang

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Product Description

The NuVasive TLX Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients with at least six months of non-operative treatment. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems for use in the thoracolumbar spine. The TLX Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). The NuVasive TLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0507980
Registration Date
April 10, 2023
Retention Due Date
April 09, 2026
Product Owner
Short Name
Nuvasive
Address
7475 Lusk Blvd, San Diego, CA 92121, UNITED STATES
Registrant
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Importer
Address
151 LORONG CHUAN, NEW TECH PARK, #04-03, SINGAPORE 556741
Model Information
Model Name(s)
TLX Implant, 7x11x25mm 15° TLX Implant, 7x11x26mm 15° TLX Implant, 7x11x30mm 15° TLX Implant, 7x11x35mm 12° TLX Implant, 7x11x40mm 9° TLX Implant, 8x11x25mm 15° TLX Implant, 8x11x26mm 15° TLX Implant, 8x11x30mm 15° TLX Implant, 8x11x35mm 12° TLX Implant, 8x11x40mm 10° TLX Implant, 9x11x25mm 15° TLX Implant, 9x11x26mm 15° TLX Implant, 9x11x30mm 15° TLX Implant, 9x11x35mm 15° TLX Implant, 9x11x40mm 12° TLX Implant, 10x11x25mm 15° TLX Implant, 10x11x26mm 15° TLX Implant, 10x11x30mm 15° TLX Implant, 10x11x35mm 15° TLX Implant, 10x11x40mm 12° TLX Implant, 11x11x25mm 15° TLX Implant, 11x11x26mm 15° TLX Implant, 11x11x30mm 15° TLX Implant, 11x11x35mm 15° TLX Implant, 11x11x40mm 12° TLX Implant, 12x11x25mm 15° TLX Implant, 12x11x26mm 15° TLX Implant, 12x11x30mm 15° TLX Implant, 12x11x35mm 15° TLX Implant, 12x11x40mm 12° TLX Implant, 13x11x25mm 15° TLX Implant, 13x11x26mm 15° TLX Implant, 13x11x30mm 15° TLX Implant, 13x11x35mm 15° TLX Implant, 13x11x40mm 12° TLX Implant, 14x11x25mm 15° TLX Implant, 14x11x26mm 15° TLX Implant, 14x11x30mm 15° TLX Implant, 14x11x35mm 15° TLX Implant, 14x11x40mm 12° TLX Implant, 15x11x25mm 15° TLX Implant, 15x11x26mm 15° TLX Implant, 15x11x30mm 15° TLX Implant, 15x11x35mm 15° TLX Implant, 15x11x40mm 12° TLX Implant, 16x11x25mm 15° TLX Implant, 16x11x26mm 15° TLX Implant, 16x11x30mm 15° TLX Implant, 16x11x35mm 15° TLX Implant, 16x11x40mm 12° TLX Implant, 7x13x25mm 15° TLX Implant, 7x13x26mm 15° TLX Implant, 7x13x30mm 15° TLX Implant, 7x13x35mm 12° TLX Implant, 7x13x40mm 10° TLX Implant, 8x13x25mm 15° TLX Implant, 8x13x26mm 15° TLX Implant, 8x13x30mm 15° TLX Implant, 8x13x35mm 12° TLX Implant, 8x13x40mm 10° TLX Implant, 9x13x25mm 15° TLX Implant, 9x13x26mm 15° TLX Implant, 9x13x30mm 15° TLX Implant, 9x13x35mm 15° TLX Implant, 9x13x40mm 12° TLX Implant, 10x13x25mm 15° TLX Implant, 10x13x26mm 15° TLX Implant, 10x13x30mm 15° TLX Implant, 10x13x35mm 15° TLX Implant, 10x13x40mm 12° TLX Implant, 11x13x25mm 15° TLX Implant, 11x13x26mm 15° TLX Implant, 11x13x30mm 15° TLX Implant, 11x13x35mm 15° TLX Implant, 11x13x40mm 12° TLX Implant, 12x13x25mm 15° TLX Implant, 12x13x26mm 15° TLX Implant, 12x13x30mm 15° TLX Implant, 12x13x35mm 15° TLX Implant, 12x13x40mm 12° TLX Implant, 13x13x25mm 15° TLX Implant, 13x13x26mm 15° TLX Implant, 13x13x30mm 15° TLX Implant, 13x13x35mm 15° TLX Implant, 13x13x40mm 12° TLX Implant, 14x13x25mm 15° TLX Implant, 14x13x26mm 15° TLX Implant, 14x13x30mm 15° TLX Implant, 14x13x35mm 15° TLX Implant, 14x13x40mm 12° TLX Implant, 15x13x25mm 15° TLX Implant, 15x13x26mm 15° TLX Implant, 15x13x30mm 15° TLX Implant, 15x13x35mm 15° TLX Implant, 15x13x40mm 12° TLX Implant, 16x13x25mm 15° TLX Implant, 16x13x26mm 15° TLX Implant, 16x13x30mm 15° TLX Implant, 16x13x35mm 15° TLX Implant, 16x13x40mm 12° TLX Implant, 7x11x26mm 20° TLX Implant, 7x11x27mm 20° TLX Implant, 7x11x31mm 20° TLX Implant, 8x11x26mm 20° TLX Implant, 8x11x27mm 20° TLX Implant, 8x11x31mm 20° TLX Implant, 9x11x26mm 20° TLX Implant, 9x11x27mm 20° TLX Implant, 9x11x31mm 20° TLX Implant, 10x11x26mm 20° TLX Implant, 10x11x27mm 20° TLX Implant, 10x11x31mm 20° TLX Implant, 11x11x26mm 20° TLX Implant, 11x11x27mm 20° TLX Implant, 11x11x31mm 20° TLX Implant, 12x11x26mm 20° TLX Implant, 12x11x27mm 20° TLX Implant, 12x11x31mm 20° TLX Implant, 13x11x26mm 20° TLX Implant, 13x11x27mm 20° TLX Implant, 13x11x31mm 20° TLX Implant, 14x11x26mm 20° TLX Implant, 14x11x27mm 20° TLX Implant, 14x11x31mm 20° TLX Implant, 15x11x26mm 20° TLX Implant, 15x11x27mm 20° TLX Implant, 15x11x31mm 20° TLX Implant, 16x11x26mm 20° TLX Implant, 16x11x27mm 20° TLX Implant, 16x11x31mm 20° TLX Implant, 7x13x26mm 20° TLX Implant, 7x13x27mm 20° TLX Implant, 7x13x31mm 20° TLX Implant, 8x13x26mm 20° TLX Implant, 8x13x27mm 20° TLX Implant, 8x13x31mm 20° TLX Implant, 9x13x26mm 20° TLX Implant, 9x13x27mm 20° TLX Implant, 9x13x31mm 20° TLX Implant, 10x13x26mm 20° TLX Implant, 10x13x27mm 20° TLX Implant, 10x13x31mm 20° TLX Implant, 11x13x26mm 20° TLX Implant, 11x13x27mm 20° TLX Implant, 11x13x31mm 20° TLX Implant, 11x13x36mm 15° TLX Implant, 12x13x26mm 20° TLX Implant, 12x13x27mm 20° TLX Implant, 12x13x31mm 20° TLX Implant, 12x13x36mm 15° TLX Implant, 13x13x26mm 20° TLX Implant, 13x13x27mm 20° TLX Implant, 13x13x31mm 20° TLX Implant, 13x13x36mm 15° TLX Implant, 14x13x26mm 20° TLX Implant, 14x13x27mm 20° TLX Implant, 14x13x31mm 20° TLX Implant, 14x13x36mm 15° TLX Implant, 15x13x26mm 20° TLX Implant, 15x13x27mm 20° TLX Implant, 15x13x31mm 20° TLX Implant, 15x13x36mm 15° TLX Implant, 16x13x26mm 20° TLX Implant, 16x13x27mm 20° TLX Implant, 16x13x31mm 20° TLX Implant, 16x13x36mm 15° TLX Implant, 10x11x26mm 15° TLX Implant, 10x11x27mm 15° TLX Implant, 10x11x31mm 15° TLX Implant, 10x11x36mm 15° TLX Implant, 10x11x40mm 12° TLX Implant, 10x13x26mm 15° TLX Implant, 10x13x27mm 15° TLX Implant, 10x13x31mm 15° TLX Implant, 10x13x36mm 15° TLX Implant, 10x13x40mm 12° TLX Implant, 11x11x26mm 15° TLX Implant, 11x11x27mm 15° TLX Implant, 11x11x31mm 15° TLX Implant, 11x11x36mm 15° TLX Implant, 11x11x40mm 12° TLX Implant, 11x13x26mm 15° TLX Implant, 11x13x27mm 15° TLX Implant, 11x13x31mm 15° TLX Implant, 11x13x36mm 15° TLX Implant, 11x13x40mm 12° TLX Implant, 12x11x26mm 15° TLX Implant, 12x11x27mm 15° TLX Implant, 12x11x31mm 15° TLX Implant, 12x11x36mm 15° TLX Implant, 12x11x40mm 12° TLX Implant, 12x13x26mm 15° TLX Implant, 12x13x27mm 15° TLX Implant, 12x13x31mm 15° TLX Implant, 12x13x36mm 15° TLX Implant, 12x13x40mm 12° TLX Implant, 13x11x26mm 15° TLX Implant, 13x11x27mm 15° TLX Implant, 13x11x31mm 15° TLX Implant, 13x11x36mm 15° TLX Implant, 13x11x40mm 12° TLX Implant, 13x13x26mm 15° TLX Implant, 13x13x27mm 15° TLX Implant, 13x13x31mm 15° TLX Implant, 13x13x36mm 15° TLX Implant, 13x13x40mm 12° TLX Implant, 14x11x26mm 15° TLX Implant, 14x11x27mm 15° TLX Implant, 14x11x31mm 15° TLX Implant, 14x11x36mm 15° TLX Implant, 14x11x40mm 12° TLX Implant, 14x13x26mm 15° TLX Implant, 14x13x27mm 15° TLX Implant, 14x13x31mm 15° TLX Implant, 14x13x36mm 15° TLX Implant, 14x13x40mm 12° TLX Implant, 15x11x26mm 15° TLX Implant, 15x11x27mm 15° TLX Implant, 15x11x31mm 15° TLX Implant, 15x11x36mm 15° TLX Implant, 15x11x40mm 12° TLX Implant, 15x13x26mm 15° TLX Implant, 15x13x27mm 15° TLX Implant, 15x13x31mm 15° TLX Implant, 15x13x36mm 15° TLX Implant, 15x13x40mm 12° TLX Implant, 16x11x26mm 15° TLX Implant, 16x11x27mm 15° TLX Implant, 16x11x31mm 15° TLX Implant, 16x11x36mm 15° TLX Implant, 16x11x40mm 12° TLX Implant, 16x13x26mm 15° TLX Implant, 16x13x27mm 15° TLX Implant, 16x13x31mm 15° TLX Implant, 16x13x36mm 15° TLX Implant, 16x13x40mm 12° TLX Implant, 7x11x26mm 15° TLX Implant, 7x11x27mm 15° TLX Implant, 7x11x31mm 15° TLX Implant, 7x11x36mm 12° TLX Implant, 7x11x40mm 9° TLX Implant, 7x13x26mm 15° TLX Implant, 7x13x27mm 15° TLX Implant, 7x13x31mm 15° TLX Implant, 7x13x36mm 12° TLX Implant, 7x13x40mm 10° TLX Implant, 8x11x26mm 15° TLX Implant, 8x11x27mm 15° TLX Implant, 8x11x31mm 15° TLX Implant, 8x11x36mm 12° TLX Implant, 8x11x40mm 10° TLX Implant, 8x13x26mm 15° TLX Implant, 8x13x27mm 15° TLX Implant, 8x13x31mm 15° TLX Implant, 8x13x36mm 12° TLX Implant, 8x13x40mm 10° TLX Implant, 9x11x26mm 15° TLX Implant, 9x11x27mm 15° TLX Implant, 9x11x31mm 15° TLX Implant, 9x11x36mm 15° TLX Implant, 9x11x40mm 12° TLX Implant, 9x13x26mm 15° TLX Implant, 9x13x27mm 15° TLX Implant, 9x13x31mm 15° TLX Implant, 9x13x36mm 15° TLX Implant, 9x13x40mm 12° TLX20, 10x13x26mm 20° TLX20, 10x13x27mm 20° TLX20, 10x13x31mm 20° TLX20, 11x13x26mm 20° TLX20, 11x13x27mm 20° TLX20, 11x13x31mm 20° TLX20, 12x13x26mm 20° TLX20, 12x13x27mm 20° TLX20, 12x13x31mm 20° TLX20, 13x13x26mm 20° TLX20, 13x13x27mm 20° TLX20, 13x13x31mm 20° TLX20, 14x13x26mm 20° TLX20, 14x13x27mm 20° TLX20, 14x13x31mm 20° TLX20, 15x13x26mm 20° TLX20, 15x13x27mm 20° TLX20, 15x13x31mm 20° TLX20, 16x13x26mm 20° TLX20, 16x13x27mm 20° TLX20, 16x13x31mm 20° TLX20, 7x13x26mm 20° TLX20, 7x13x27mm 20° TLX20, 7x13x31mm 20° TLX20, 8x13x26mm 20° TLX20, 8x13x27mm 20° TLX20, 8x13x31mm 20° TLX20, 9x13x26mm 20° TLX20, 9x13x27mm 20° TLX20, 9x13x31mm 20° TLX20, 10x13x41mm 13° TLX20, 11x13x41mm 13° TLX20, 12x13x41mm 13° TLX20, 13x13x41mm 13° TLX20, 14x13x41mm 13° TLX20, 15x13x41mm 13° TLX20, 16x13x41mm 13° TLX20, 7x13x36mm 13° TLX20, 8x13x36mm 13° TLX20, 9x13x41mm 13° TLX20, 7x13x41mm 10° TLX20, 8x13x41mm 10° TLX20, 10x13x36mm 15° TLX20, 11x13x36mm 15° TLX20, 12x13x36mm 15° TLX20, 13x13x36mm 15° TLX20, 14x13x36mm 15° TLX20, 15x13x36mm 15° TLX20, 16x13x36mm 15° TLX20, 9x13x36mm 15° TLX20, 7x11x41mm 10° TLX20, 8x11x41mm 10° TLX20, 10x11x26mm 20° TLX20, 10x11x27mm 20° TLX20, 10x11x31mm 20° TLX20, 11x11x26mm 20° TLX20, 11x11x27mm 20° TLX20, 11x11x31mm 20° TLX20, 12x11x26mm 20° TLX20, 12x11x27mm 20° TLX20, 12x11x31mm 20° TLX20, 13x11x26mm 20° TLX20, 13x11x27mm 20° TLX20, 13x11x31mm 20° TLX20, 14x11x26mm 20° TLX20, 14x11x27mm 20° TLX20, 14x11x31mm 20° TLX20, 15x11x26mm 20° TLX20, 15x11x27mm 20° TLX20, 15x11x31mm 20° TLX20, 16x11x26mm 20° TLX20, 16x11x27mm 20° TLX20, 16x11x31mm 20° TLX20, 7x11x26mm 20° TLX20, 7x11x27mm 20° TLX20, 7x11x31mm 20° TLX20, 8x11x26mm 20° TLX20, 8x11x27mm 20° TLX20, 8x11x31mm 20° TLX20, 9x11x26mm 20° TLX20, 9x11x27mm 20° TLX20, 9x11x31mm 20° TLX20, 10x11x41mm 13° TLX20, 11x11x41mm 13° TLX20, 12x11x41mm 13° TLX20, 13x11x41mm 13° TLX20, 14x11x41mm 13° TLX20, 15x11x41mm 13° TLX20, 16x11x41mm 13° TLX20, 7x11x36mm 13° TLX20, 8x11x36mm 13° TLX20, 9x11x41mm 13° TLX20, 10x11x36mm 15° TLX20, 11x11x36mm 15° TLX20, 12x11x36mm 15° TLX20, 13x11x36mm 15° TLX20, 14x11x36mm 15° TLX20, 15x11x36mm 15° TLX20, 16x11x36mm 15° TLX20, 9x11x36mm 15°
Model Identifier(s)
1742601 1742602 1742603 1742604 1742605 1742606 1742607 1742608 1742609 1742610 1742611 1742612 1742613 1742614 1742615 1742616 1742617 1742618 1742619 1742620 1742621 1742622 1742623 1742624 1742625 1742626 1742627 1742628 1742629 1742630 1742631 1742632 1742633 1742634 1742635 1742636 1742637 1742638 1742639 1742640 1742641 1742642 1742643 1742644 1742645 1742646 1742647 1742648 1742649 1742650 1742651 1742652 1742653 1742654 1742655 1742656 1742657 1742658 1742659 1742660 1742661 1742662 1742663 1742664 1742665 1742666 1742667 1742668 1742669 1742670 1742671 1742672 1742673 1742674 1742675 1742676 1742677 1742678 1742679 1742680 1742681 1742682 1742683 1742684 1742685 1742686 1742687 1742688 1742689 1742690 1742691 1742692 1742693 1742694 1742695 1742696 1742697 1742698 1742699 1742700 1792601 1792602 1792603 1792606 1792607 1792608 1792611 1792612 1792613 1792616 1792617 1792618 1792621 1792622 1792623 1792626 1792627 1792628 1792631 1792632 1792633 1792636 1792637 1792638 1792641 1792642 1792643 1792646 1792647 1792648 1792651 1792652 1792653 1792656 1792657 1792658 1792661 1792662 1792663 1792666 1792667 1792668 1792671 1792672 1792673 1792674 1792676 1792677 1792678 1792679 1792681 1792682 1792683 1792684 1792686 1792687 1792688 1792689 1792691 1792692 1792693 1792694 1792696 1792697 1792698 1792699 5801255 5801265 5801305 5801355 5801402 5803255 5803265 5803305 5803355 5803402 5811255 5811265 5811305 5811355 5811402 5813255 5813265 5813305 5813355 5813402 5821255 5821265 5821305 5821355 5821402 5823255 5823265 5823305 5823355 5823402 5831255 5831265 5831305 5831355 5831402 5833255 5833265 5833305 5833355 5833402 5841255 5841265 5841305 5841355 5841402 5843255 5843265 5843305 5843355 5843402 5851255 5851265 5851305 5851355 5851402 5853255 5853265 5853305 5853355 5853402 5861255 5861265 5861305 5861355 5861402 5863255 5863265 5863305 5863355 5863402 5871255 5871265 5871305 5871352 5871409 5873255 5873265 5873305 5873352 5873400 5881255 5881265 5881305 5881352 5881400 5883255 5883265 5883305 5883352 5883400 5891255 5891265 5891305 5891355 5891402 5893255 5893265 5893305 5893355 5893402 5894026P2 5894027P2 5894031P2 5894126P2 5894127P2 5894131P2 5894226P2 5894227P2 5894231P2 5894326P2 5894327P2 5894331P2 5894426P2 5894427P2 5894431P2 5894526P2 5894527P2 5894531P2 5894626P2 5894627P2 5894631P2 5894726P2 5894727P2 5894731P2 5894826P2 5894827P2 5894831P2 5894926P2 5894927P2 5894931P2 5895041P2 5895141P2 5895241P2 5895341P2 5895441P2 5895541P2 5895641P2 5895736P2 5895836P2 5895941P2 5896741P2 5896841P2 5897036P2 5897136P2 5897236P2 5897336P2 5897436P2 5897536P2 5897636P2 5897936P2 5900741P2 5900841P2 5902026P2 5902027P2 5902031P2 5902126P2 5902127P2 5902131P2 5902226P2 5902227P2 5902231P2 5902326P2 5902327P2 5902331P2 5902426P2 5902427P2 5902431P2 5902526P2 5902527P2 5902531P2 5902626P2 5902627P2 5902631P2 5902726P2 5902727P2 5902731P2 5902826P2 5902827P2 5902831P2 5902926P2 5902927P2 5902931P2 5903041P2 5903141P2 5903241P2 5903341P2 5903441P2 5903541P2 5903641P2 5903736P2 5903836P2 5903941P2 5905036P2 5905136P2 5905236P2 5905336P2 5905436P2 5905536P2 5905636P2 5905936P2