FDA 510(k)

TRIGEN HINDFOOT FUSION NAIL

K-Number: K043052 · 2004-11-24

Decision Date2004-11-24

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRIGEN HINDFOOT FUSION NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K043052. 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 TRIGEN HINDFOOT FUSION NAIL?

TRIGEN HINDFOOT FUSION NAIL is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K043052.

When did TRIGEN HINDFOOT FUSION NAIL receive FDA 510(k) clearance?

TRIGEN HINDFOOT FUSION NAIL received FDA 510(k) clearance on 2004-11-24, under 510(k) number K043052.

Who is the listed applicant for TRIGEN HINDFOOT FUSION NAIL?

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

What is the FDA product code for TRIGEN HINDFOOT FUSION NAIL?

The FDA product code for TRIGEN HINDFOOT FUSION NAIL is HSB.

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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.