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FDA 510(k)

LAURE WRIST IMPLANT

K-Number: K803031 · 1982-06-29

ApplicantLaure Prosthetics, Inc.
Decision Date1982-06-29
Product CodeKWM
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LAURE WRIST IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Laure Prosthetics, Inc.. It received FDA 510(k) clearance on 1982-06-29 under 510(k) number K803031. 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 LAURE WRIST IMPLANT?

LAURE WRIST IMPLANT is a medical device that received FDA 510(k) clearance on 1982-06-29. The listed applicant is Laure Prosthetics, Inc.. The 510(k) number is K803031.

When did LAURE WRIST IMPLANT receive FDA 510(k) clearance?

LAURE WRIST IMPLANT received FDA 510(k) clearance on 1982-06-29, under 510(k) number K803031.

Who is the listed applicant for LAURE WRIST IMPLANT?

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

What is the FDA product code for LAURE WRIST IMPLANT?

The FDA product code for LAURE WRIST IMPLANT is KWM.

Related Clinical Trials

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.

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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.

K880156VOLZ TOTAL WRIST PROSTHESISBiomet, Inc.K872502M.W.P. WRIST PROSTHESISProtek, Inc.K800602TALEISNIK TOTAL WRIST PROSTHESISDow Corning WrightK801157WEBER-MAYO WRISTDepuy, Inc.K790774LODA WRIST PROSTHESISDepuy, Inc.

Official Source

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

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