FDA 510(k)

HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT

K-Number: K955871 · 1996-03-22

Decision Date1996-03-22

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HOWMEDICA ASYMMETRIC STEM 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 1996-03-22 under 510(k) number K955871. 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 HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT?

HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1996-03-22. The listed applicant is Howmedica Corp.. The 510(k) number is K955871.

When did HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT receive FDA 510(k) clearance?

HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT received FDA 510(k) clearance on 1996-03-22, under 510(k) number K955871.

Who is the listed applicant for HOWMEDICA ASYMMETRIC STEM 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 HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT?

The FDA product code for HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT is LPH.

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Other records listing Howmedica Corp. as applicant

K983528MICRO DYNAMIC MESH K983404TYPE 3 FEMORAL COMPONENTS K980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION K980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION K980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION K980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.