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Biomet Choice Instruments - HSA Registration DE0503758

Access comprehensive regulatory information for Biomet Choice 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 DE0503758 and owned by Biomet Orthopedics. The device was registered on October 22, 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
DE0503758
Biomet Choice Instruments
HSA Registration Number: DE0503758
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Product Description

A device that is an interchangeable component of an orthopaedic osteotome and functions as the cutting blade which is attached and locked to a dedicated handle. Together, this becomes a single-bladed, chisel-like, surgical instrument, typically bevelled on either side with sloping curves, that is intended to be used to cut and/or shape bone by percussion during an orthopaedic procedure where the bone is typically used as a transplant. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will be made of high-grade stainless steel and is reusable.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0503758
Registration Date
October 22, 2019
Retention Due Date
October 21, 2025
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)
Choice Instruments Modular Calcar Planer Set
Model Identifier(s)
406660