FDA 510(k)

TaperSet™ Hip System

N.º K: K252846 · 2025-11-20

SolicitanteShalby Advanced Technologies, Inc. Dba Consensus Orthopedics

Fecha de decisión2025-11-20

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

TaperSet™ Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K252846. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TaperSet™ Hip System?

TaperSet™ Hip System is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. The 510(k) number is K252846.

When did TaperSet™ Hip System receive FDA 510(k) clearance?

TaperSet™ Hip System received FDA 510(k) clearance on 2025-11-20, under 510(k) number K252846.

Who is the listed applicant for TaperSet™ Hip System?

The FDA 510(k) record lists Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TaperSet™ Hip System?

The FDA product code for TaperSet™ Hip System is LPH.

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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 K251270Taperloc® Complete Hip StemBiomet, Inc.

Fuente oficial

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