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FDA 510(k)

FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND

K-Number: K931265 · 1995-05-22

Decision Date1995-05-22
Product CodeJWI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND is the device name listed in this FDA 510(k) record. The listed applicant is Ferguson Medical. It received FDA 510(k) clearance on 1995-05-22 under 510(k) number K931265. The device is classified under product code JWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND?

FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND is a medical device that received FDA 510(k) clearance on 1995-05-22. The listed applicant is Ferguson Medical. The 510(k) number is K931265.

When did FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND receive FDA 510(k) clearance?

FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND received FDA 510(k) clearance on 1995-05-22, under 510(k) number K931265.

Who is the listed applicant for FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND?

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

What is the FDA product code for FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND?

The FDA product code for FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND is JWI.

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.

Other records listing Ferguson Medical 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.

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Related Devices (Code: JWI)

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.

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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