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Globus Medical REFLECT Scoliosis Correction System - HSA Registration DE0502358

Access comprehensive regulatory information for Globus Medical REFLECT Scoliosis Correction 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 DE0502358 and owned by Globus Medical Inc.. The device was registered on November 19, 2018.

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
DE0502358
Globus Medical REFLECT Scoliosis Correction System
HSA Registration Number: DE0502358
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Product Description

The REFLECT™ Scoliosis Correction System is intended to provide spinal alignment and stabilization of the thoracolumbar spine in the treatment of spinal deformity. REFLECT™ implants are indicated for use in the treatment of deformities or curvatures of the spine in skeletally immature patients with adolescent idiopathic scoliosis using growth modulation and in skeletally mature patients with thoracolumbar deformity using correctional stabilization. Screw fixation is achieved using CREO® monoaxial screws for anterolateral screw fixation (T1-L5). Staples may be used in conjunction with anterolateral screws for additional fixation.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0502358
Registration Date
November 19, 2018
Change Notification Approval Date
March 05, 2025
Retention Due Date
November 18, 2025
Product Owner
Short Name
Globus Medical Inc.
Address
Valley Forge Business Center, 2560 General Armistead Avenue, Audubon, PA 19403, Pennsylvania, 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 30 KALLANG PLACE, #06-06, SINGAPORE 339159
Model Information
Model Name(s)
CREO 4.75 Locking Cap CREO 4.75 Locking Cap 4.75mm Grip End Rod, Titanium Alloy, 250mm Length REFLECT Cord with Collet, 250mm REFLECT 5.0mm Cord with Collet, 250mm REFLECT Cord with Collet, 350mm REFLECT 5.0mm Cord with Collet, 350mm 7.5mm Threaded Staple, 3 Prong 7.5mm Threaded Staple, 3 Prong 7.0mm Threaded Staple, 3 Prong 7.0mm Threaded Staple, 3 Prong 6.5mm Threaded Staple, 3 Prong 6.5mm Threaded Staple, 3 Prong 6.0mm Threaded Staple, 3 Prong 6.0mm Threaded Staple, 3 Prong 5.5mm Threaded Staple, 3 Prong 5.5mm Threaded Staple, 3 Prong 5.0mm Threaded Staple, 3 Prong 5.0mm Threaded Staple, 3 Prong 4.5mm Threaded Staple, 3 Prong 4.5mm Threaded Staple, 3 Prong 4.0mm Threaded Staple, 3 Prong 4.0mm Threaded Staple, 3 Prong REFLECT Cord, 250mm CREO 4.75, 5.0 x 20mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 22.5mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 25mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 27.5mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 30mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 32.5mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 35mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 37.5mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 40mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 45mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 50mm HA Coated Monoaxial Screw CREO 4.75, 5.0 x 55mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 20mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 22.5mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 25mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 27.5mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 30mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 32.5mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 35mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 37.5mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 40mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 45mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 50mm HA Coated Monoaxial Screw CREO 4.75, 5.5 x 55mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 20mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 22.5mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 25mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 27.5mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 30mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 32.5mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 35mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 37.5mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 40mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 45mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 50mm HA Coated Monoaxial Screw CREO 4.75, 6.5 x 55mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 20mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 22.5mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 25mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 27.5mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 30mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 32.5mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 35mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 37.5mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 40mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 45mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 50mm HA Coated Monoaxial Screw CREO 4.75, 6.0 x 55mm HA Coated Monoaxial Screw CREO 4.75 HA Coated Monoxial Screws Set CREO 4.75 Implants and Thoracoscopic Instruments I Set Thoracoscopic Instruments II Set
Model Identifier(s)
1067.0000 1067.0000S 1067.2205 1140.1250S 1140.1251S 1140.1350S 1140.1351S 129.600 129.600S 129.601 129.601S 129.602 129.602S 129.603 129.603S 129.604 129.604S 129.605 129.605S 129.606 129.606S 129.607 129.607S 4140.0250S 5067.0421S 5067.0424S 5067.0426S 5067.0429S 5067.0431S 5067.0434S 5067.0436S 5067.0439S 5067.0441S 5067.0446S 5067.0451S 5067.0456S 5067.0521S 5067.0524S 5067.0526S 5067.0529S 5067.0531S 5067.0534S 5067.0536S 5067.0539S 5067.0541S 5067.0546S 5067.0551S 5067.0556S 5067.0621S 5067.0624S 5067.0626S 5067.0629S 5067.0631S 5067.0634S 5067.0636S 5067.0639S 5067.0641S 5067.0646S 5067.0651S 5067.0656S 5067.1021S 5067.1024S 5067.1026S 5067.1029S 5067.1031S 5067.1034S 5067.1036S 5067.1039S 5067.1041S 5067.1046S 5067.1051S 5067.1056S 9067.9801 9067.9802 9067.9803