FDA 510(k)

HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS

K-Number: K921525 · 1995-01-11

Decision Date1995-01-11

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Implant Technology, Inc.. It received FDA 510(k) clearance on 1995-01-11 under 510(k) number K921525. 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 HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS?

HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Implant Technology, Inc.. The 510(k) number is K921525.

When did HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS receive FDA 510(k) clearance?

HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS received FDA 510(k) clearance on 1995-01-11, under 510(k) number K921525.

Who is the listed applicant for HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS?

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

What is the FDA product code for HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS?

The FDA product code for HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS is LPH.

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Other records listing Implant Technology, Inc. as applicant

K915617LSF HA COATED FEMORAL HIP K920021LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP K913616LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP K902727LSF CEMENTED FEMORAL HIP K901460LSF(TM) TOTAL HIP SYSTEM K891472IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR

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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.