FDA 510(k)

P.C.A. E-SERIES HIP- CEMENTLESS USE

K-Number: K945093 · 1995-01-19

Decision Date1995-01-19

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent for Some Indications

Device Summary

P.C.A. E-SERIES HIP- CEMENTLESS USE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1995-01-19 under 510(k) number K945093. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the P.C.A. E-SERIES HIP- CEMENTLESS USE?

P.C.A. E-SERIES HIP- CEMENTLESS USE is a medical device that received FDA 510(k) clearance on 1995-01-19. The listed applicant is Howmedica, Inc.. The 510(k) number is K945093.

When did P.C.A. E-SERIES HIP- CEMENTLESS USE receive FDA 510(k) clearance?

P.C.A. E-SERIES HIP- CEMENTLESS USE received FDA 510(k) clearance on 1995-01-19, under 510(k) number K945093.

Who is the listed applicant for P.C.A. E-SERIES HIP- CEMENTLESS USE?

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

What is the FDA product code for P.C.A. E-SERIES HIP- CEMENTLESS USE?

The FDA product code for P.C.A. E-SERIES HIP- CEMENTLESS USE is LZO.

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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.