FDA 510(k)

PRECISION OSTELOCK SP FEMORAL COMPONENT

K-Number: K941141 · 1994-09-28

Decision Date1994-09-28

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PRECISION OSTELOCK SP 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 1994-09-28 under 510(k) number K941141. 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 PRECISION OSTELOCK SP FEMORAL COMPONENT?

PRECISION OSTELOCK SP FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1994-09-28. The listed applicant is Howmedica Corp.. The 510(k) number is K941141.

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

PRECISION OSTELOCK SP FEMORAL COMPONENT received FDA 510(k) clearance on 1994-09-28, under 510(k) number K941141.

Who is the listed applicant for PRECISION OSTELOCK SP 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 OSTELOCK SP FEMORAL COMPONENT?

The FDA product code for PRECISION OSTELOCK SP FEMORAL COMPONENT is LPH.

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Other records listing Howmedica Corp. as applicant

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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.