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FDA 510(k)

GAMMA LOCKING NAIL - LONG LENGTH

K-Number: K944883 · 1994-11-28

ApplicantHowmedica Corp.
Decision Date1994-11-28
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAMMA LOCKING NAIL - LONG LENGTH is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1994-11-28 under 510(k) number K944883. 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 - LONG LENGTH?

GAMMA LOCKING NAIL - LONG LENGTH is a medical device that received FDA 510(k) clearance on 1994-11-28. The listed applicant is Howmedica Corp.. The 510(k) number is K944883.

When did GAMMA LOCKING NAIL - LONG LENGTH receive FDA 510(k) clearance?

GAMMA LOCKING NAIL - LONG LENGTH received FDA 510(k) clearance on 1994-11-28, under 510(k) number K944883.

Who is the listed applicant for GAMMA LOCKING NAIL - LONG LENGTH?

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 GAMMA LOCKING NAIL - LONG LENGTH?

The FDA product code for GAMMA LOCKING NAIL - LONG LENGTH is KTT.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Related Devices (Code: KTT)

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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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