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Stryker System 9 - HSA Registration DE0508227

Access comprehensive regulatory information for Stryker System 9 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508227 and owned by Stryker Instruments. The device was registered on June 22, 2023.

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 B
DE0508227
Stryker System 9
HSA Registration Number: DE0508227
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Product Description

System 9 Cordless Driver Handpiece, Sabo™ Sagittal Saw are intended to cut hard tissue and/or bone. System 9 EZOut Saw is intended to cut bone and hard tissue around the bone-to-cup interface to aid in the removal of a hemispherical acetabular cup during revision of hip arthroplasty. System 9 Single and Dual Trigger Rotary Handpieces are intended for use in the drilling, reaming, and decorticating of bone and other bone- related tissue, placement of screws, wires, pins, and other fixation devices. System 9 Reciprocating Saw, Sternum Saw, Sagittal Saw, Stryker Precision® Saw are intended for use in the cutting and shaping of bone and other bone- related tissue.The Stryker CD NXT Handpiece is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue for the placement of screws, wires, pins, plates, and other fixation devices.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508227
Registration Date
June 22, 2023
Change Notification Approval Date
March 14, 2025
Retention Due Date
June 21, 2025
Product Owner
Short Name
Stryker Instruments
Address
1941 Stryker Way, Portage MI 49002, UNITED STATES
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)
System 9 Cordless Driver Handpiece System 9 CD NXT Handpiece C2CTM Drill Bit 1.5 x 99mm C2CTM Drill Bit 1.6 x 99mm C2CTM Drill Bit 1.8 x 99mm C2CTM Drill Bit 1.9 x 99mm C2CTM Drill Bit 2.0 x 99mm C2CTM Drill Bit 2.3 x 99mm C2CTM Drill Bit 2.4 x 99mm C2CTM Drill Bit 2.5 x 99mm C2CTM Drill Bit 2.6 x 99mm C2CTM Drill Bit 2.7 x 99mm C2CTM Drill Bit 2.8 x 99mm C2CTM Drill Bit 2.9 x 99mm C2CTM Drill Bit 3.0 x 99mm C2CTM Drill Bit 3.1 x 99mm C2CTM Drill Bit 3.2 x 99mm C2CTM Drill Bit 3.3 x 99mm C2CTM Drill Bit 2.0 x 129mm C2CTM Drill Bit 2.4 X 129MM C2CTM Drill Bit 2.5 x 129mm C2CTM Drill Bit 2.6 x 129mm C2CTM Drill Bit 2.7 x 129mm C2CTM Drill Bit 2.8 x 129mm C2CTM Drill Bit 3.0 x 129mm C2CTM Drill Bit 3.1 x 129mm C2CTM Drill Bit 3.2 x 129mm C2CTM Drill Bit 3.5 x 129mm C2CTM Drill Bit 3.8 x 129mm C2CTM Drill Bit 4.0 x 129mm C2CTM Drill Bit 4.3 x 129mm C2CTM Drill Bit 4.5 x 129mm C2CTM Drill Bit 2.0 x 149mm C2CTM Drill Bit 2.5 x 149mm C2C DRILL BIT 2.8 X 149MM C2CTM Drill Bit 3.1 x 149mm C2CTM Drill Bit 3.5 x 149mm C2CTM Drill Bit 3.5 x 149mm C2CTM Drill Bit 4.3 x 149mm C2CTM Drill Bit 4.5 x 149mm C2CTM Drill Bit 2.5 x 169mm C2CTM Drill Bit 3.1 x 169mm C2CTM Drill Bit 3.2 x 169mm C2CTM Drill Bit 4.3 x 169mm C2CTM Drill Bit 4.5 x 169mm C2C Head Attachment System 9 Sabo™ Sagittal Saw System 9 EZOut® Saw System 9 Single Trigger Rotary Handpiece System 9 Dual Trigger Rotary Handpiece System 9 Reciprocating Saw System 9 Sternum Saw System 9 Sagittal Saw System 9 Stryker Precision® Saw
Model Identifier(s)
4605-000-000 4607-000-000 4607-099-015 4607-099-016 4607-099-018 4607-099-019 4607-099-020 4607-099-023 4607-099-024 4607-099-025 4607-099-026 4607-099-027 4607-099-028 4607-099-029 4607-099-030 4607-099-031 4607-099-032 4607-099-033 4607-129-020 4607-129-024 4607-129-025 4607-129-026 4607-129-027 4607-129-028 4607-129-030 4607-129-031 4607-129-032 4607-129-035 4607-129-038 4607-129-040 4607-129-043 4607-129-045 4607-149-020 4607-149-025 4607-149-028 4607-149-031 4607-149-032 4607-149-035 4607-149-043 4607-149-045 4607-169-025 4607-169-031 4607-169-032 4607-169-043 4607-169-045 4607-300-032 4608-000-000 9202-000-000 9203-000-000 9205-000-000 9206-000-000 9207-000-000 9208-000-000 9209-000-000