FDA 510(k)

TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM

K-Number: K921301 · 1994-02-16

Decision Date1994-02-16

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1994-02-16 under 510(k) number K921301. 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 FEMORAL STEM AND UNIVERSAL ACETABULAR COM?

TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM is a medical device that received FDA 510(k) clearance on 1994-02-16. The listed applicant is Biomet, Inc.. The 510(k) number is K921301.

When did TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM receive FDA 510(k) clearance?

TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM received FDA 510(k) clearance on 1994-02-16, under 510(k) number K921301.

Who is the listed applicant for TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM?

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

What is the FDA product code for TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM?

The FDA product code for TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM is LPH.

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Other records listing Biomet, Inc. as applicant

K253434OSSTM Orthopedic Salvage System K251270Taperloc® Complete Hip Stem K241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer Molds K221968StageOne™ Shoulder Cement Spacer Molds K213287StageOne Knee Cement Spacer Molds

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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.