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FDA 510(k)

VOLZ TOTAL WRIST PROSTHESIS

K-Number: K880156 · 1988-02-17

ApplicantBiomet, Inc.
Decision Date1988-02-17
Product CodeKWM
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VOLZ TOTAL WRIST PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1988-02-17 under 510(k) number K880156. The device is classified under product code KWM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLZ TOTAL WRIST PROSTHESIS?

VOLZ TOTAL WRIST PROSTHESIS is a medical device that received FDA 510(k) clearance on 1988-02-17. The listed applicant is Biomet, Inc.. The 510(k) number is K880156.

When did VOLZ TOTAL WRIST PROSTHESIS receive FDA 510(k) clearance?

VOLZ TOTAL WRIST PROSTHESIS received FDA 510(k) clearance on 1988-02-17, under 510(k) number K880156.

Who is the listed applicant for VOLZ TOTAL WRIST PROSTHESIS?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOLZ TOTAL WRIST PROSTHESIS?

The FDA product code for VOLZ TOTAL WRIST PROSTHESIS is KWM.

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Other records listing Biomet, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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Related Devices (Code: KWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K872502M.W.P. WRIST PROSTHESISProtek, Inc.K803031LAURE WRIST IMPLANTLaure Prosthetics, Inc.K800602TALEISNIK TOTAL WRIST PROSTHESISDow Corning WrightK801157WEBER-MAYO WRISTDepuy, Inc.K790774LODA WRIST PROSTHESISDepuy, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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