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FDA 510(k)

ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM

K-Number: K042440 · 2004-10-07

ApplicantAlphatec/Nexmed
Decision Date2004-10-07
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec/Nexmed. It received FDA 510(k) clearance on 2004-10-07 under 510(k) number K042440. 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 ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM?

ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Alphatec/Nexmed. The 510(k) number is K042440.

When did ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM receive FDA 510(k) clearance?

ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042440.

Who is the listed applicant for ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM?

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

What is the FDA product code for ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM?

The FDA product code for ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM 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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