FDA 510(k)

PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)

K-Number: K925172 · 1994-02-22

Decision Date1994-02-22

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE) is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K925172. 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(R) E SERIES HIP SYSTEM (CEMENTLESS USE)?

PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE) is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Howmedica Corp.. The 510(k) number is K925172.

When did PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE) receive FDA 510(k) clearance?

PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE) received FDA 510(k) clearance on 1994-02-22, under 510(k) number K925172.

Who is the listed applicant for PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)?

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 PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)?

The FDA product code for PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE) is LPH.

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Other records listing Howmedica Corp. as applicant

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Related Devices (Code: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.

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.