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Stryker VariAx Fibula Locking Plate System - HSA Registration DE0019146

Access comprehensive regulatory information for Stryker VariAx Fibula Locking Plate 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 DE0019146 and owned by Stryker GmbH. The device was registered on April 10, 2017.

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
DE0019146
Stryker VariAx Fibula Locking Plate System
HSA Registration Number: DE0019146
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Product Description

The VariAx Fibula Locking Plate System is intended for use in internal fixation of the distal fibula

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0019146
Registration Date
April 10, 2017
Change Notification Approval Date
April 26, 2021
Retention Due Date
April 09, 2026
Product Owner
Short Name
Stryker GmbH
Address
Bohnackerweg 1, 2545 Selzach, SWITZERLAND
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
Straight Plate VariAx Fibula, 2 Hole / L28.5mm Straight Plate VariAx Fibula, 2 Hole / L28.5mm Straight Plate VariAx Fibula, 3 Hole / L40.5mm Straight Plate VariAx Fibula, 3 Hole / L40.5mm Straight Plate VariAx Fibula, 4 Hole / L60mm Straight Plate VariAx Fibula, 4 Hole / L60mm Straight Plate VariAx Fibula, 5 Hole / L72mm Straight Plate VariAx Fibula, 5 Hole / L72mm Straight Plate VariAx Fibula, 6 Hole / L84mm Straight Plate VariAx Fibula, 6 Hole / L84mm Straight Plate VariAx Fibula, 7 Hole / L96mm Straight Plate VariAx Fibula, 7 Hole / L96mm Straight Plate VariAx Fibula, 8 Hole / L108mm Straight Plate VariAx Fibula, 8 Hole / L108mm Straight Plate VariAx Fibula, 10 Hole / L132mm Straight Plate VariAx Fibula, 10 Hole / L132mm Straight Plate VariAx Fibula, 12 Hole / L156mm Straight Plate VariAx Fibula, 12 Hole / L156mm Straight Plate VariAx Fibula, 14 Hole / L180mm Straight Plate VariAx Fibula, 14 Hole / L180mm Straight Plate VariAx Fibula, 16 Hole / L204mm Straight Plate VariAx Fibula, 16 Hole / L204mm DISTAL LATERAL FIBULA PLATE, 3 HOLE DISTAL LATERAL FIBULA PLATE, 3 HOLE, STERILE DISTAL LATERAL FIBULA PLATE, 4 HOLE DISTAL LATERAL FIBULA PLATE, 4 HOLE, STERILE DISTAL LATERAL FIBULA PLATE, 5 HOLE DISTAL LATERAL FIBULA PLATE, 5 HOLE, STERILE DISTAL LATERAL FIBULA PLATE, 6 HOLE DISTAL LATERAL FIBULA PLATE, 6 HOLE, STERILE DISTAL LATERAL FIBULA PLATE, 7 HOLE DISTAL LATERAL FIBULA PLATE, 7 HOLE, STERILE DISTAL LATERAL FIBULA PLATE, 8 HOLE DISTAL LATERAL FIBULA PLATE, 8 HOLE, STERILE DDISTAL LATERAL FIBULA PLATE, 9 HOLE DISTAL LATERAL FIBULA PLATE, 9 HOLE, STERILE DISTAL LATERAL FIBULA PLATE, 10 HOLE, STERILE DISTAL LATERAL FIBULA PLATE, 12 HOLE, STERILE BONE SCREW, T10, 3.5X10MM BONE SCREW, T10, 3.5X12MM BONE SCREW, T10, 3.5X14MM BONE SCREW, T10, 3.5X16MM BONE SCREW, T10, 3.5X18MM BONE SCREW, T10, 3.5X20MM BONE SCREW, T10, 3.5X22MM BONE SCREW, T10, 3.5X24MM BONE SCREW, T10, 3.5X26MM BONE SCREW, T10, 3.5X28MM BONE SCREW, T10, 3.5X30MM BONE SCREW, T10, 3.5X32MM BONE SCREW, T10, 3.5X34MM BONE SCREW, T10, 3.5X36MM BONE SCREW, T10, 3.5X38MM BONE SCREW, T10, 3.5X40MM BONE SCREW, T10, 3.5X42MM BONE SCREW, T10, 3.5X44MM BONE SCREW, T10, 3.5X46MM BONE SCREW, T10, 3.5X48MM BONE SCREW, T10, 3.5X50MM BONE SCREW, T10, 3.5X55MM BONE SCREW, T10, 3.5X60MM BONE SCREW, T10, 3.5X65MM BONE SCREW, T10, 3.5X70MM LOCKING SCREW, T10, 3.5X10MM LOCKING SCREW, T10, 3.5X12MM LOCKING SCREW, T10, 3.5X14MM LOCKING SCREW, T10, 3.5X16MM LOCKING SCREW, T10, 3.5X18MM LOCKING SCREW, T10, 3.5X20MM LOCKING SCREW, T10, 3.5X22MM LOCKING SCREW, T10, 3.5X24MM LOCKING SCREW, T10, 3.5X26MM LOCKING SCREW, T10, 3.5X28MM LOCKING SCREW, T10, 3.5X30MM LOCKING SCREW, T10, 3.5X32MM LOCKING SCREW, T10, 3.5X34MM LOCKING SCREW, T10, 3.5X36MM LOCKING SCREW, T10, 3.5X38MM LOCKING SCREW, T10, 3.5X40MM LOCKING SCREW, T10, 3.5X42MM LOCKING SCREW, T10, 3.5X44MM LOCKING SCREW, T10, 3.5X46MM LOCKING SCREW, T10, 3.5X48MM LOCKING SCREW, T10, 3.5X50MM LOCKING SCREW, T10, 3.5X55MM LOCKING SCREW, T10, 3.5X60MM LOCKING SCREW, T10, 3.5X65MM LOCKING SCREW, T10, 3.5X70MM WASHER FOR 3.5MM BONE SCREW WASHER FOR 3.5MM BONE SCREW TWIST DRILL, DIAM.2.6X122MM, WL 70MM, AO-SHAFT TWIST DRILL, DIAM.2.6X122MM, WL 70MM, AO-SHAFT TWIST DRILL, DIAM.3.6X122MM, AO-SHAFT K-WIRE, FULLY THREADED, 1.6MMX200MM K-WIRE, FULLY THREADED, 1.6MMX200MM K-WIRE, SMOOTH, 1.4MMX100MM K-WIRE, SMOOTH, 1.4MMX100MM STEINMANN PIN, SMOOTH, 2.5MMX100MM Drill Bit ø2.0mm x 122mm AO Fitting For 2.7mm Screw Drill Bit ø2.6mm x 122mm AO Fitting For 3.5mm Screw Drill Bit ø2.7mm x 122mm AO Fitting For 2.7mm Overdrill Drill Bit ø3.5mm x 122mm AO Fitting For 3.5mm Overdrill K-Wire Clamp ø2.0mm & smaller Kirschner Wire with Stop VariAx ø2mm / 150mm with ø4.5mm Stop Drill Bit VariAx ø2.6mm x 220mm, AO Tap AO, For 3.5mm Screws Tap AO, For 2.7mm Screws SpeedGuide TM Drill, AO, Dia 2.0mm (L = 30mm) SpeedGuide TM Drill, AO, Dia 2.6mm (L = 30mm)
Model Identifier(s)
4020802 4020802S 4020803 4020803S 4020804 4020804S 4020805 4020805S 4020806 4020806S 4020807 4020807S 4020808 4020808S 4020810 4020810S 4020812 4020812S 4020814 4020814S 4020816 4020816S 4020903 4020903S 4020904 4020904S 4020905 4020905S 4020906 4020906S 4020907 4020907S 4020908 4020908S 4020909 4020909S 4020910S 4020912S 4035010 4035012 4035014 4035016 4035018 4035020 4035022 4035024 4035026 4035028 4035030 4035032 4035034 4035036 4035038 4035040 4035042 4035044 4035046 4035048 4035050 4035055 4035060 4035065 4035070 4035610 4035612 4035614 4035616 4035618 4035620 4035622 4035624 4035626 4035628 4035630 4035632 4035634 4035636 4035638 4035640 4035642 4035644 4035646 4035648 4035650 4035655 4035660 4035665 4035670 4035900 4035900S 4535010 4535010S 4535020 4580100 4580100S 4580200 4580200S 4580300 703701 703702 703703 703704 703716 703818 703824 703898 703899 703933 703934