FDA 510(k)

POROUS TITANIUM ACETABULAR SHELLS

K-Number: K052996 · 2006-04-28

Decision Date2006-04-28

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

POROUS TITANIUM ACETABULAR SHELLS 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 2006-04-28 under 510(k) number K052996. 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 POROUS TITANIUM ACETABULAR SHELLS?

POROUS TITANIUM ACETABULAR SHELLS is a medical device that received FDA 510(k) clearance on 2006-04-28. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K052996.

When did POROUS TITANIUM ACETABULAR SHELLS receive FDA 510(k) clearance?

POROUS TITANIUM ACETABULAR SHELLS received FDA 510(k) clearance on 2006-04-28, under 510(k) number K052996.

Who is the listed applicant for POROUS TITANIUM ACETABULAR SHELLS?

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 POROUS TITANIUM ACETABULAR SHELLS?

The FDA product code for POROUS TITANIUM ACETABULAR SHELLS 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.