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FDA 510(k)

TRABECULAR METAL ACETABULAR REVISION SHELLS

K-Number: K050937 · 2005-05-11

ApplicantZimmer Trabecular
Decision Date2005-05-11
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRABECULAR METAL ACETABULAR REVISION SHELLS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular. It received FDA 510(k) clearance on 2005-05-11 under 510(k) number K050937. 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 TRABECULAR METAL ACETABULAR REVISION SHELLS?

TRABECULAR METAL ACETABULAR REVISION SHELLS is a medical device that received FDA 510(k) clearance on 2005-05-11. The listed applicant is Zimmer Trabecular. The 510(k) number is K050937.

When did TRABECULAR METAL ACETABULAR REVISION SHELLS receive FDA 510(k) clearance?

TRABECULAR METAL ACETABULAR REVISION SHELLS received FDA 510(k) clearance on 2005-05-11, under 510(k) number K050937.

Who is the listed applicant for TRABECULAR METAL ACETABULAR REVISION SHELLS?

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

What is the FDA product code for TRABECULAR METAL ACETABULAR REVISION SHELLS?

The FDA product code for TRABECULAR METAL ACETABULAR REVISION SHELLS is LPH.

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Other records listing Zimmer Trabecular as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061155VISTA P VERTEBRAL BODY REPLACEMENT SYSTEMK061067TRABECULAR METAL ACETABULAR AUGMENTSK053340TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTSK052950THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEMK051756MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZK050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM

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Related Devices (Code: LPH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 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 OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® 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.

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