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Stryker PRO System - HSA Registration DE0016534

Access comprehensive regulatory information for Stryker PRO 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 DE0016534 and owned by Stryker GmbH. The device was registered on November 10, 2014.

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
DE0016534
Stryker PRO System
HSA Registration Number: DE0016534
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Product Description

The Stryker Pelvic ll system is intended for the fractures of the following regions of the pelvis ring: Anterior Column, Anterior Column combined with posterior hemi-transverse and Quadrilateral surface.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
HSA Product Code
HSAMDC00107
HS Code
90219000
Registration Information
Registration Number
DE0016534
Registration Date
November 10, 2014
Change Notification Approval Date
December 01, 2020
Retention Due Date
November 09, 2025
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
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
Cortex Screw S.T. Ø3.5x12mm Cortex Screw S.T. Ø3.5x14mm Cortex Screw S.T. Ø3.5x16mm Cortex Screw S.T. Ø3.5x18mm Cortex Screw S.T. Ø3.5x20mm Cortex Screw S.T. Ø3.5x22mm Cortex Screw S.T. Ø3.5x24mm Cortex Screw S.T. Ø3.5x26mm Cortex Screw S.T. Ø3.5x28mm Cortex Screw S.T. Ø3.5x30mm Cortex Screw S.T. Ø3.5x32mm Cortex Screw S.T. Ø3.5x34mm Cortex Screw S.T. Ø3.5x36mm Cortex Screw S.T. Ø3.5x38mm Cortex Screw S.T. Ø3.5x40mm Cortex Screw S.T. Ø3.5x42mm Cortex Screw S.T. Ø3.5x44mm Cortex Screw S.T. Ø3.5x45mm Cortex Screw S.T. Ø3.5x46mm Cortex Screw S.T. Ø3.5x48mm Cortex Screw S.T. Ø3.5x50mm Cortex Screw S.T. Ø3.5x55mm Cortex Screw S.T. Ø3.5x60mm Cortex Screw S.T. Ø3.5x65mm Cortex Screw S.T. Ø3.5x70mm Cortex Screw S.T. Ø3.5x75mm Cortex Screw S.T. Ø3.5x80mm Cortex Screw S.T. Ø3.5x85mm Cortex Screw S.T. Ø3.5x90mm Cortex Screw S.T. Ø3.5x95mm Cortex Screw S.T. Ø3.5x100mm Cortex Screw S.T. Ø3.5x105mm Cortex Screw S.T. Ø3.5x110mm Cortex Screw S.T. Ø4.5x14mm Cortex Screw S.T. Ø4.5x16mm Cortex Screw S.T. Ø4.5x18mm Cortex Screw S.T. Ø4.5x20mm Cortex Screw S.T. Ø4.5x22mm Cortex Screw S.T. Ø4.5x24mm Cortex Screw S.T. Ø4.5x26mm Cortex Screw S.T. Ø4.5x28mm Cortex Screw S.T. Ø4.5x30mm Cortex Screw S.T. Ø4.5x32mm Cortex Screw S.T. Ø4.5x34mm Cortex Screw S.T. Ø4.5x36mm Cortex Screw S.T. Ø4.5x38mm Cortex Screw S.T. Ø4.5x40mm Cortex Screw S.T. Ø4.5x42mm Cortex Screw S.T. Ø4.5x44mm Cortex Screw S.T. Ø4.5x46mm Cortex Screw S.T. Ø4.5x48mm Cortex Screw S.T. Ø4.5x50mm Cortex Screw S.T. Ø4.5x52mm Cortex Screw S.T. Ø4.5x54mm Cortex Screw S.T. Ø4.5x55mm Cortex Screw S.T. Ø4.5x56mm Cortex Screw S.T. Ø4.5x58mm Cortex Screw S.T. Ø4.5x60mm Cortex Screw S.T. Ø4.5x62mm Cortex Screw S.T. Ø4.5x64mm Cortex Screw S.T. Ø4.5x65mm Cortex Screw S.T. Ø4.5x66mm Cortex Screw S.T. Ø4.5x68mm Cortex Screw S.T. Ø4.5x70mm Cortex Screw S.T. Ø4.5x72mm Cortex Screw S.T. Ø4.5x74mm Cortex Screw S.T. Ø4.5x75mm Cortex Screw S.T. Ø4.5x76mm Cortex Screw S.T. Ø4.5x78mm Cortex Screw S.T. Ø4.5x80mm Cortex Screw S.T. Ø4.5x85mm Cortex Screw S.T. Ø4.5x90mm Cortex Screw S.T. Ø4.5x95mm Cortex Screw S.T. Ø4.5x100mm Cortex Screw S.T. Ø4.5x105mm Cortex Screw S.T. Ø4.5x110mm Cortex Screw S.T. Ø4.5x115mm Cortex Screw S.T. Ø4.5x120mm Reduction Pin Dia. 5.0mm Length 150mm AO Fitting Reduction Pin Dia. 5.0mm Length 180mm AO Fitting Suprapectineal Plate Stryker Pelvis II QLS Right Suprapectineal Plate Stryker Pelvis II QLS Left Infrapectineal Plate Stryker Pelvis II Large, QLS Right Infrapectineal Plate Stryker Pelvis II Large, QLS Left Infrapectineal Plate Stryker Pelvis II Small, QLS Right Infrapectineal Plate Stryker Pelvis II Small, QLS Left Drill Bit Ø2.5x180mm AO Fitting Drill Bit Ø3.5x180mm AO Fitting Drill Bit Ø4.5x180mm AO Fitting Drill Bit Ø2.5x230mm AO Fitting Drill Bit Ø3.2x180mm AO Fitting Drill Bit Ø3.2x230mm AO Fitting Drilling guide Ø4.5/3.2mm Drilling guide Ø3.5/2.5mm Elastosil T-Handle small AO Coupling Elastosil Handle small AO Coupling Elastosil Handle large AO Coupling Tap Ø3.5x180mm AO Fitting Tap Ø4.5x180mm AO Fitting Tap Ø6.5x180mm AO Fitting Countersink For Screws: Ø2.7/3.5/4.0mm AO Fitting Countersink For Screws: Ø4.5/6.5mm AO Fitting Screwdriver Hex 2.5mm Elastosil Handle Screwdriver Hex 3.5mm Elastosil Handle Screwdriver Hex 2.5mm AO Fitting Screwdriver Hex 3.5mm AO Fitting Holding Sleeve for Screwdrivers For Screws: Ø3.5/4.0mm Holding Sleeve for Screwdrivers For Screws: ø4.5/6.5mm Depth Gauge For Screws: Ø2.7/3.5/4.0mm Depth Gauge For Screws: Ø4.5/6.5mm Bending Iron for Pelvic Plates Straight Ball Spike Straight Ball Spike AO Fitting Sciatic nerve retractor Short Sciatic nerve retractor Long Spiked Disk Pubic Tubercle Retractor Stryker Pelvis II Acetabular Rim Retractor Stryker Pelvis II Iliac Retractor Stryker Pelvis II Suction Retractor Stryker Pelvis II K-Wire Stryker Pelvis II ø3.2mm x L150mm Cleaning Stylet Stryker Pelvis II Suction Retractor Angled Ball Spike Stryker Pelvis II 15 deg Angled Ball Spike Stryker Pelvis II 30 deg Spiked Screw Inserter Stryker Pelvis II For 3.5 Screws Spiked Disk Stryker Pelvis II For 3.5 Spiked Screw Inserter Washer Pick-up Stand Stryker Pelvis II Handle for Plate Insertion Stryker Pelvis II Plate Screw Inserter Stryker Pelvis II Drill Sleeve Stryker Pelvis II For 3.5 Spiked Screw Inserter Scaled Drill Stryker Pelvis II ø2.5mm, AO Fitting Screwdriver Stryker Pelvis II Hex 2.5mm, Elastosil Handle Screwdriver Stryker Pelvis II Hex 2.5mm, AO Fitting Plate Bending Holder Stryker Pelvis II Plate Bender Stryker Pelvis II Bending Stick Stryker Pelvis II Flexible Depth Gauge Stryker Pelvis II Ø2.5mm Basic Instruments Tray P&A System Basic Tray Insert Silicon Mat for Basic Tray Retractors Tray
Model Identifier(s)
338612 338614 338616 338618 338620 338622 338624 338626 338628 338630 338632 338634 338636 338638 338640 338642 338644 338645 338646 338648 338650 338655 338660 338665 338670 338675 338680 338685 338690 338695 338700 338705 338710 340614 340616 340618 340620 340622 340624 340626 340628 340630 340632 340634 340636 340638 340640 340642 340644 340646 340648 340650 340652 340654 340655 340656 340658 340660 340662 340664 340665 340666 340668 340670 340672 340674 340675 340676 340678 340680 340685 340690 340695 340700 340705 340710 340715 340720 390083 390084 425911 425912 425921 425922 425931 425932 700351 700353 700354 700355 700356 700357 702417 702418 702427 702428 702429 702804 702806 702807 702811 702812 702842 702843 702851 702853 702861 702862 702876 702877 702902 702911 702912 702915 702916 702923 703950 703951 703952 703953 703954S 703955 703958 703959 703960 703961 703962 703963 703964 703965 703966 703967 703968 703969 703970 703971 703976 940070 940073 940074 940075