FDA 510(k)

EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR

K-Number: K921114 · 1993-10-27

Decision Date1993-10-27

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1993-10-27 under 510(k) number K921114. 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 EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR?

EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR is a medical device that received FDA 510(k) clearance on 1993-10-27. The listed applicant is Exactech, Inc.. The 510(k) number is K921114.

When did EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR receive FDA 510(k) clearance?

EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR received FDA 510(k) clearance on 1993-10-27, under 510(k) number K921114.

Who is the listed applicant for EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR?

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

What is the FDA product code for EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR?

The FDA product code for EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR is LPH.

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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.