FDA 510(k)

XR-SERIES BI-METRIC FEMORAL COMPONENTS

K-Number: K052089 · 2006-02-17

Decision Date2006-02-17

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

XR-SERIES BI-METRIC FEMORAL COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2006-02-17 under 510(k) number K052089. 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 XR-SERIES BI-METRIC FEMORAL COMPONENTS?

XR-SERIES BI-METRIC FEMORAL COMPONENTS is a medical device that received FDA 510(k) clearance on 2006-02-17. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K052089.

When did XR-SERIES BI-METRIC FEMORAL COMPONENTS receive FDA 510(k) clearance?

XR-SERIES BI-METRIC FEMORAL COMPONENTS received FDA 510(k) clearance on 2006-02-17, under 510(k) number K052089.

Who is the listed applicant for XR-SERIES BI-METRIC FEMORAL COMPONENTS?

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

What is the FDA product code for XR-SERIES BI-METRIC FEMORAL COMPONENTS?

The FDA product code for XR-SERIES BI-METRIC FEMORAL COMPONENTS is LPH.

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Other records listing Biomet Manufacturing, Inc. as applicant

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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.