FDA 510(k)

TAPERLOC COMPLETE SIZE 4MM AND XR 123

K-Number: K120030 · 2012-08-17

Decision Date2012-08-17

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TAPERLOC COMPLETE SIZE 4MM AND XR 123 is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2012-08-17 under 510(k) number K120030. 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 TAPERLOC COMPLETE SIZE 4MM AND XR 123?

TAPERLOC COMPLETE SIZE 4MM AND XR 123 is a medical device that received FDA 510(k) clearance on 2012-08-17. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K120030.

When did TAPERLOC COMPLETE SIZE 4MM AND XR 123 receive FDA 510(k) clearance?

TAPERLOC COMPLETE SIZE 4MM AND XR 123 received FDA 510(k) clearance on 2012-08-17, under 510(k) number K120030.

Who is the listed applicant for TAPERLOC COMPLETE SIZE 4MM AND XR 123?

The FDA 510(k) record lists Biomet Manufacturing Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TAPERLOC COMPLETE SIZE 4MM AND XR 123?

The FDA product code for TAPERLOC COMPLETE SIZE 4MM AND XR 123 is LPH.

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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.