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FDA 510(k)

GAMMA LOCKING NAIL MODIFICATION

K-Number: K940286 · 1994-03-14

ApplicantHowmedica, Inc.
Decision Date1994-03-14
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAMMA LOCKING NAIL MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1994-03-14 under 510(k) number K940286. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA LOCKING NAIL MODIFICATION?

GAMMA LOCKING NAIL MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-03-14. The listed applicant is Howmedica, Inc.. The 510(k) number is K940286.

When did GAMMA LOCKING NAIL MODIFICATION receive FDA 510(k) clearance?

GAMMA LOCKING NAIL MODIFICATION received FDA 510(k) clearance on 1994-03-14, under 510(k) number K940286.

Who is the listed applicant for GAMMA LOCKING NAIL MODIFICATION?

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

What is the FDA product code for GAMMA LOCKING NAIL MODIFICATION?

The FDA product code for GAMMA LOCKING NAIL MODIFICATION is KTT.

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Other records listing Howmedica, 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.

K984251XIA SPINE SYSTEMK984202HOWMEDICA HUMERAL INTERCALARY SYSTEMK984305ZETA MULTIZONE LOCKING NAIL SYSTEMK983885BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATESK983358G/K SFN AND STN LOCKING NAILSK982463EXTRACRANIAL RADIOTHERAPY SYSTEM

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Related Devices (Code: KTT)

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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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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