FDA 510(k)

PCA 36MM FEMORAL HEADS

K-Number: K061168 · 2006-07-18

Decision Date2006-07-18

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PCA 36MM FEMORAL HEADS 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 2006-07-18 under 510(k) number K061168. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCA 36MM FEMORAL HEADS?

PCA 36MM FEMORAL HEADS is a medical device that received FDA 510(k) clearance on 2006-07-18. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K061168.

When did PCA 36MM FEMORAL HEADS receive FDA 510(k) clearance?

PCA 36MM FEMORAL HEADS received FDA 510(k) clearance on 2006-07-18, under 510(k) number K061168.

Who is the listed applicant for PCA 36MM FEMORAL HEADS?

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 PCA 36MM FEMORAL HEADS?

The FDA product code for PCA 36MM FEMORAL HEADS is LPH.

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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.