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FDA 510(k)

BRIGHAM TOTAL ANKLE PROSTHESIS

K-Number: K803167 · 1981-02-19

ApplicantHowmedica Corp.
Decision Date1981-02-19
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BRIGHAM TOTAL ANKLE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1981-02-19 under 510(k) number K803167. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIGHAM TOTAL ANKLE PROSTHESIS?

BRIGHAM TOTAL ANKLE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1981-02-19. The listed applicant is Howmedica Corp.. The 510(k) number is K803167.

When did BRIGHAM TOTAL ANKLE PROSTHESIS receive FDA 510(k) clearance?

BRIGHAM TOTAL ANKLE PROSTHESIS received FDA 510(k) clearance on 1981-02-19, under 510(k) number K803167.

Who is the listed applicant for BRIGHAM TOTAL ANKLE PROSTHESIS?

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

What is the FDA product code for BRIGHAM TOTAL ANKLE PROSTHESIS?

The FDA product code for BRIGHAM TOTAL ANKLE PROSTHESIS is HSN.

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Other records listing Howmedica Corp. as applicant

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Related Devices (Code: HSN)

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.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

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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