Stryker® AVS™ TL PEEK Spacer - HSA Registration DE0004212

Access comprehensive regulatory information for Stryker® AVS™ TL PEEK Spacer in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0004212 and owned by Stryker Spine. The device was registered on March 10, 2008.

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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HSA Official Data

CLASS C

DE0004212

Stryker® AVS™ TL PEEK Spacer

HSA Registration Number: DE0004212

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Product Description

A vertebral body replacement indicated for use in the thoraco-lumbar spine (L1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebractomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. it is recommended to pack bone graft material inside the implant.The device is intended for use with supplemental fixation, which include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Device Classification

Device Class

CLASS C

Medical Speciality Area

Orthopaedics

HSA Product Code

HSAMDC00107

HS Code

90219000

Registration Information

Registration Number

DE0004212

Registration Date

March 10, 2008

Change Notification Approval Date

March 22, 2010

Retention Due Date

August 09, 2025

Product Owner

Name

Stryker Spine

Short Name

Stryker

Address

Z.I. de Marticot, 33610 Cestas, FRANCE

Registrant

Name

STRYKER SINGAPORE PRIVATE LIMITED

Address

1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145

Importer

Name

STRYKER SINGAPORE PRIVATE LIMITED

Address

1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145

Model Information

Model Name(s)

T-handle VERTEBRAL SPACER 9 x 30 x 0° VERTEBRAL SPACER 9 x 30 x 4° VERTEBRAL SPACER 10 x 30 x 0° VERTEBRAL SPACER 10 x 30 x 4° VERTEBRAL SPACER 11 x 30 x 0° VERTEBRAL SPACER 11 x 30 x 4° VERTEBRAL SPACER 12 x 30 x 0° VERTEBRAL SPACER 12 x 30 x 4° VERTEBRAL SPACER 13 x 30 x 0° VERTEBRAL SPACER 13 x 30 x 4° VERTEBRAL SPACER 14 x 30 x 0° VERTEBRAL SPACER 14 x 30 x 4° VERTEBRAL SPACER 15 x 30 x 0° VERTEBRAL SPACER 15 x 30 x 4° VERTEBRAL SPACER 16 x 30 x 0° VERTEBRAL SPACER 16 x 30 x 4° VERTEBRAL SPACER 17 x 30 x 0° VERTEBRAL SPACER 17 x 30 x 4° VERTEBRAL SPACER 18 x 30 x 0° VERTEBRAL SPACER 18 x 30 x 4° VERTEBRAL SPACER 7 x 25 x 0° VERTEBRAL SPACER 7 x 25 x 4° VERTEBRAL SPACER 8 x 25 x 0° VERTEBRAL SPACER 8 x 25 x 4° VERTEBRAL SPACER 9 x 25 x 0° VERTEBRAL SPACER 9 x 25 x 4° VERTEBRAL SPACER 10 x 25 x 0° VERTEBRAL SPACER 10 x 25 x 4° VERTEBRAL SPACER 11 x 25 x 0° VERTEBRAL SPACER 11 x 25 x 4° VERTEBRAL SPACER 12 x 25 x 0° VERTEBRAL SPACER 12 x 25 x 4° VERTEBRAL SPACER 13 x 25 x 0° VERTEBRAL SPACER 13 x 25 x 4° VERTEBRAL SPACER 14 x 25 x 0° VERTEBRAL SPACER 14 x 25 x 4° VERTEBRAL SPACER 15 x 25 x 0° VERTEBRAL SPACER 15 x 25 x 4° VERTEBRAL SPACER 16 x 25 x 0° VERTEBRAL SPACER 16 x 25 x 4° VERTEBRAL SPACER 17 x 25 x 0° VERTEBRAL SPACER 17 x 25 x 4° VERTEBRAL SPACER 18 x 25 x 0° VERTEBRAL SPACER 18 x 25 x 4° TL Spacer Inserter Straight TL Spacer Inserter Angled TL Spacer Support TL Spacer Graft Compactor TL Spacer Impactor Straight TL Spacer Impactor Angled Trial Spacer Size 7 Trial Spacer Size 8 Trial Spacer Size 9 Trial Spacer Size 10 Trial Spacer Size 11 Trial Spacer Size 12 Trial Spacer Size 13 Trial Spacer Size 14 Trial Spacer Size 15 Trial Spacer Size 16

Model Identifier(s)

48361000 48380090 48380094 48380100 48380104 48380110 48380114 48380120 48380124 48380130 48380134 48380140 48380144 48380150 48380154 48380160 48380164 48380170 48380174 48380180 48380184 48385070 48385074 48385080 48385084 48385090 48385094 48385100 48385104 48385110 48385114 48385120 48385124 48385130 48385134 48385140 48385144 48385150 48385154 48385160 48385164 48385170 48385174 48385180 48385184 48389100 48389150 48389200 48389250 48389300 48389350 48389407 48389408 48389409 48389410 48389411 48389412 48389413 48389414 48389415 48389416