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FDA 510(k)

GAMMA 3 LAG SCREW

K-Number: K020677 · 2002-03-29

ApplicantHowmedica Osteonics Corp.
Decision Date2002-03-29
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAMMA 3 LAG SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2002-03-29 under 510(k) number K020677. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA 3 LAG SCREW?

GAMMA 3 LAG SCREW is a medical device that received FDA 510(k) clearance on 2002-03-29. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K020677.

When did GAMMA 3 LAG SCREW receive FDA 510(k) clearance?

GAMMA 3 LAG SCREW received FDA 510(k) clearance on 2002-03-29, under 510(k) number K020677.

Who is the listed applicant for GAMMA 3 LAG SCREW?

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

What is the FDA product code for GAMMA 3 LAG SCREW?

The FDA product code for GAMMA 3 LAG SCREW is HSB.

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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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