FDA 510(k)

PRECISION OSTEOLOCK FEMORAL COMPONENT

K-Number: K944592 · 1995-05-17

Decision Date1995-05-17

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent for Some Indications

Device Summary

PRECISION OSTEOLOCK FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1995-05-17 under 510(k) number K944592. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PRECISION OSTEOLOCK FEMORAL COMPONENT?

PRECISION OSTEOLOCK FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1995-05-17. The listed applicant is Howmedica Corp.. The 510(k) number is K944592.

When did PRECISION OSTEOLOCK FEMORAL COMPONENT receive FDA 510(k) clearance?

PRECISION OSTEOLOCK FEMORAL COMPONENT received FDA 510(k) clearance on 1995-05-17, under 510(k) number K944592.

Who is the listed applicant for PRECISION OSTEOLOCK FEMORAL COMPONENT?

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 PRECISION OSTEOLOCK FEMORAL COMPONENT?

The FDA product code for PRECISION OSTEOLOCK FEMORAL COMPONENT 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.