Pure Global

Globus Medical Sustain Radiolucent Spacer, Oblique - HSA Registration DE0501295

Access comprehensive regulatory information for Globus Medical Sustain Radiolucent Spacer, Oblique in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501295 and owned by Globus Medical Inc.. The device was registered on March 01, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0501295
Globus Medical Sustain Radiolucent Spacer, Oblique
HSA Registration Number: DE0501295
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The SUSTAIN-O Spacers are interbody fusion devices intended for use in the lumbosacral (L1-S1), for lumbar interbody fusion in the treatment of degenerative disorders of the lumbosacral spine. These spacers are recommended to be used with supplemental spinal fixation systems for the lumbosacral spine (e.g. pedicle screw and rod systems, or plates).

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0501295
Registration Date
March 01, 2018
Change Notification Approval Date
March 05, 2025
Retention Due Date
February 28, 2026
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)
SUSTAIN Radiolucent Spacer, Oblique, 10x26, 8mm SUSTAIN Radiolucent Spacer, Oblique, 10x26, 9mm SUSTAIN Radiolucent Spacer, Oblique, 10x26, 10mm SUSTAIN Radiolucent Spacer, Oblique, 10x26, 11mm SUSTAIN Radiolucent Spacer, Oblique, 10x26, 12mm SUSTAIN Radiolucent Spacer, Oblique, 10x26, 13mm SUSTAIN Radiolucent Spacer, Oblique, 10x26, 14mm SUSTAIN Radiolucent Spacer, Oblique, 10x26, 15mm SUSTAIN Radiolucent Spacer, Oblique, 10x26, 16mm SUSTAIN Radiolucent Spacer, Oblique, 10x26, 17mm SUSTAIN Radiolucent Spacer, Oblique, Small, 8x22, 8mm SUSTAIN Radiolucent Spacer, Oblique, Small, 8x22, 9mm SUSTAIN Radiolucent Spacer, Oblique, Small, 8x22, 10mm SUSTAIN Radiolucent Spacer, Oblique, Small, 8x22, 11mm SUSTAIN Radiolucent Spacer, Oblique, Small, 8x22, 12mm SUSTAIN Radiolucent Spacer, Oblique, Small, 8x22, 13mm SUSTAIN Radiolucent Spacer, Oblique, Small, 8x22, 14mm SUSTAIN Radiolucent Spacer, Oblique, Small, 8x22, 15mm SUSTAIN Radiolucent Spacer, Oblique, Small, 8x22, 16mm SUSTAIN Radiolucent Spacer, Oblique, Small, 8x22, 17mm SUSTAIN Radiolucent Spacer, Oblique, Small, 10x22, 8mm SUSTAIN Radiolucent Spacer, Oblique, Small, 10x22, 9mm SUSTAIN Radiolucent Spacer, Oblique, Small, 10x22, 10mm SUSTAIN Radiolucent Spacer, Oblique, Small, 10x22, 11mm SUSTAIN Radiolucent Spacer, Oblique, Small, 10x22, 12mm SUSTAIN Radiolucent Spacer, Oblique, Small, 10x22, 13mm SUSTAIN Radiolucent Spacer, Oblique, Small, 10x22, 14mm SUSTAIN Radiolucent Spacer, Oblique, Small, 10x22, 15mm SUSTAIN Radiolucent Spacer, Oblique, Small, 10x22, 16mm SUSTAIN Radiolucent Spacer, Oblique, Small, 10x22, 17mm SUSTAIN Radiolucent Spacer, Oblique, 10x30, 8mm SUSTAIN Radiolucent Spacer, Oblique, 10x30, 9mm SUSTAIN Radiolucent Spacer, Oblique, 10x30, 10mm SUSTAIN Radiolucent Spacer, Oblique, 10x30, 11mm SUSTAIN Radiolucent Spacer, Oblique, 10x30, 12mm SUSTAIN Radiolucent Spacer, Oblique, 10x30, 13mm SUSTAIN Radiolucent Spacer, Oblique, 10x30, 14mm SUSTAIN Radiolucent Spacer, Oblique, 10x30, 15mm SUSTAIN Radiolucent Spacer, Oblique, 10x30, 16mm SUSTAIN Radiolucent Spacer, Oblique, 10x30, 17mm SUSTAIN Radiolucent Spacer, Oblique, 12x30, 8mm SUSTAIN Radiolucent Spacer, Oblique, 12x30, 9mm SUSTAIN Radiolucent Spacer, Oblique, 12x30, 10mm SUSTAIN Radiolucent Spacer, Oblique, 12x30, 11mm SUSTAIN Radiolucent Spacer, Oblique, 12x30, 12mm SUSTAIN Radiolucent Spacer, Oblique, 12x30, 13mm SUSTAIN Radiolucent Spacer, Oblique, 12x30, 14mm SUSTAIN Radiolucent Spacer, Oblique, 12x30, 15mm SUSTAIN Radiolucent Spacer, Oblique, 12x30, 16mm SUSTAIN Radiolucent Spacer, Oblique, 12x30, 17mm SUSTAIN Radiolucent Spacer, Oblique, 12x26, 8mm SUSTAIN Radiolucent Spacer, Oblique, 12x26, 9mm SUSTAIN Radiolucent Spacer, Oblique, 12x26, 10mm SUSTAIN Radiolucent Spacer, Oblique, 12x26, 11mm SUSTAIN Radiolucent Spacer, Oblique, 12x26, 12mm SUSTAIN Radiolucent Spacer, Oblique, 12x26, 13mm SUSTAIN Radiolucent Spacer, Oblique, 12x26, 14mm SUSTAIN Radiolucent Spacer, Oblique, 12x26, 15mm SUSTAIN Radiolucent Spacer, Oblique, 12x26, 16mm SUSTAIN Radiolucent Spacer, Oblique, 12x26, 17mm
Model Identifier(s)
304.008 304.009 304.010 304.011 304.012 304.013 304.014 304.015 304.016 304.017 304.078 304.079 304.080 304.081 304.082 304.083 304.084 304.085 304.086 304.087 304.088 304.089 304.090 304.091 304.092 304.093 304.094 304.095 304.096 304.097 304.808 304.809 304.810 304.811 304.812 304.813 304.814 304.815 304.816 304.817 304.868 304.869 304.870 304.871 304.872 304.873 304.874 304.875 304.876 304.877 304.968 304.969 304.970 304.971 304.972 304.973 304.974 304.975 304.976 304.977