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Biomet Comprehensive Surgical Instruments - HSA Registration DE0503079

Access comprehensive regulatory information for Biomet Comprehensive Surgical Instruments in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503079 and owned by Biomet Orthopedics. The device was registered on May 08, 2019.

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
DE0503079
Biomet Comprehensive Surgical Instruments
HSA Registration Number: DE0503079
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Product Description

The Biomet Comprehensive Surgical Instruments are used by a surgeon to facilitate the implantation of Comprehensive Shoulder System implantable components during shoulder arthroplasty.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0503079
Registration Date
May 08, 2019
Change Notification Approval Date
October 07, 2022
Retention Due Date
May 07, 2026
Product Owner
Short Name
Biomet Orthopedics
Address
56 East Bell Drive, P.O. Box 587, Warsaw, Indiana, 46581, UNITED STATES
Registrant
Address
401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Importer
Address
401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Model Information
Model Name(s)
Comprehensive Instruments Access 2N1 Rgx Post Cutter Comprehensive Instruments Access Quick-Release Drill/ Anti Rotation Peg 15/64" Comprehensive Instruments Access Quick-Release Peripheral Drill Shaft Comprehensive Instruments Access 3.2mm Steinmann Pin 9" Comprehensive Instruments Access Hybrid Glenoid Removal Trephine & Rod Comprehensive Instruments Access Glenoid Reamer Shaft Shoulder Glenoid Straight Reamer Shaft Steinmann Pin Threaded Tip 1/8 Dia x 2.5in long
Model Identifier(s)
110003478 110003481 110003483 110003484 110003486 110004200 402648 406669