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Stryker OASYS™ Occipito-Cervico-Thoracic System - HSA Registration DE0000886

Access comprehensive regulatory information for Stryker OASYS™ Occipito-Cervico-Thoracic 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 DE0000886 and owned by Stryker Spine. The device was registered on June 16, 2005.

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
DE0000886
Stryker OASYS™ Occipito-Cervico-Thoracic System
HSA Registration Number: DE0000886
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Product Description

It is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). It is indicated for degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous spine surgery and tumors.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
HSA Product Code
HSAMDC00107
HS Code
90219000
Registration Information
Registration Number
DE0000886
Registration Date
June 16, 2005
Change Notification Approval Date
September 29, 2014
Retention Due Date
August 09, 2025
Product Owner
Short Name
Stryker
Address
Z.I. de Marticot, 33610 Cestas, FRANCE
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
Plate Holder Implant Tray Blocker One-level Plate Two-level Plate Multi-level Plate Occiput Plate Hook, Standard Short Hook, Standard Tall Hook, Offset Right Hook, Offset Left Transverse Connector Offset Connector Rod-to-Rod Connector 3.5mmx80mm Rod 3.5mmx120mm Rod 3.5mmx240mm Rod 3.5mmx10mm polyaxial Screw 3.5mmx12mm polyaxial Screw 3.5mmx14mm polyaxial Screw 3.5mmx16mm polyaxial Screw 3.5mmx18mm polyaxial Screw 3.5mmx20mm polyaxial Screw 3.5mmx22mm polyaxial Screw 3.5mmx24mm polyaxial Screw 4.0mmx10mm polyaxial Screw 4.0mmx12mm polyaxial Screw 4.0mmx14mm polyaxial Screw 4.0mmx16mm polyaxial Screw 4.0mmx18mm polyaxial Screw 4.0mmx20mm polyaxial Screw 4.0mmx22mm polyaxial Screw 4.0mmx24mm polyaxial Screw 4.0mmx26mm polyaxial Screw 4.0mmx28mm polyaxial Screw 4.0mmx30mm polyaxial Screw 4.0mmx34mm polyaxial Screw 4.0mmx36mm polyaxial Screw 4.0mmx38mm polyaxial Screw 4.0mmx40mm polyaxial Screw 4.0mmx42mm polyaxial Screw 4.0mmx46mm polyaxial Screw 4.0mmx50mm polyaxial Screw 3.5mmx6mm Bone Screw 3.5mmx8mm Bone Screw 3.5mmx10mm Bone Screw 3.5mmx12mm Bone Screw 3.5mmx14mm Bone Screw 3.5mmx16mm Bone Screw 3.5mmx18mm Bone Screw 3.5mmx20mm Bone Screw 3.5mmx22mm Bone Screw 3.5mmx24mm Bone Screw 4.0mmx6mm Bone Screw 4.0mmx8mm Bone Screw 4.0mmx10mm Bone Screw 4.0mmx12mm Bone Screw 4.0mmx14mm Bone Screw 4.0mmx16mm Bone Screw 4.0mmx18mm Bone Screw 4.0mmx20mm Bone Screw 4.0mmx22mm Bone Screw 4.0mmx24mm Bone Screw 4.0mmx26mm Bone Screw 4.0mmx30mm Bone Screw 4.0mmx34mm Bone Screw 4.0mmx38mm Bone Screw 4.0mmx42mm Bone Screw 4.0mmx46mm Bone Screw 4.0mmx50mm Bone Screw 4.0mmx54mm Bone Screw Instrument Tray Awl Drill Guide Quick-Release Handle Probe/Depth Gauge Polyaxial Screwdriver Rod Template Rod/ Plate Cutter Rod/Plate Bender Rod Forceps Screwhead Adjuster In-situ Bender Right In-situ Bender Left Persuader Hexdriver Compression Forceps Insertion Tube/Anto-torque Key Torque-Wrench Connector Clip Inserter Plate Template Hook Preparer Hook Forceps Pedicle Probe Connector Clip Remover 3.5mm Tap 3.5MM DRILL BIT 4.0mm Tap 4.0mm Drill Tap Sleeve
Model Identifier(s)
48500300 48550000 48551000 48551010 48551020 48551030 48551040 48551050 48551055 48551060 48551065 48551070 48551080 48551090 48552080 48552120 48552240 48552310 48552312 48552314 48552316 48552318 48552320 48552322 48552324 48552410 48552412 48552414 48552416 48552418 48552420 48552422 48552424 48552426 48552428 48552430 48552434 48552436 48552438 48552440 48552442 48552446 48552450 48554306 48554308 48554310 48554312 48554314 48554316 48554318 48554320 48554322 48554324 48554406 48554408 48554410 48554412 48554414 48554416 48554418 48554420 48554422 48554424 48554426 48554430 48554434 48554438 48554442 48554446 48554450 48554454 48560000 48560010 48560011 48560012 48560015 48560016 48560017 48560018 48560019 48560020 48560021 48560022 48560023 48560024 48560025 48560026 48560027 48560028 48560029 48560030 48560032 48560033 48560115 48560129 48560314 48560323 48560414 48560423 48560914