FDA 510(k)

Taperloc® Complete Hip Stem

Número K: K251270 · 2026-05-19

Data da decisão2026-05-19

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Taperloc® Complete Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2026-05-19 under 510(k) number K251270. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Taperloc® Complete Hip Stem?

Taperloc® Complete Hip Stem is a medical device that received FDA 510(k) clearance on 2026-05-19. The listed applicant is Biomet, Inc.. The 510(k) number is K251270.

When did Taperloc® Complete Hip Stem receive FDA 510(k) clearance?

Taperloc® Complete Hip Stem received FDA 510(k) clearance on 2026-05-19, under 510(k) number K251270.

Who is the listed applicant for Taperloc® Complete Hip Stem?

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® Complete Hip Stem?

The FDA product code for Taperloc® Complete Hip Stem is LPH.

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Outros registros que listam Biomet, Inc. como candidato(a)

K253434OSSTM Orthopedic Salvage System K241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer Molds K221968StageOne™ Shoulder Cement Spacer Molds K213287StageOne Knee Cement Spacer Molds K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

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Dispositivos Relacionados (Código: 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 K252623G7® Revision Acetabular SystemZimmer, Inc.

Fonte oficial

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