FDA 510(k)

Sistema Aequalis Flex Revive Ombro

Número K: K181420 · 2018-09-20

Data da decisão2018-09-20

Código do produtoKWS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aequalis Flex Revive Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K181420. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aequalis Flex Revive Shoulder System?

Aequalis Flex Revive Shoulder System is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is Tornier, Inc.. The 510(k) number is K181420.

When did Aequalis Flex Revive Shoulder System receive FDA 510(k) clearance?

Aequalis Flex Revive Shoulder System received FDA 510(k) clearance on 2018-09-20, under 510(k) number K181420.

Who is the listed applicant for Aequalis Flex Revive Shoulder System?

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

What is the FDA product code for Aequalis Flex Revive Shoulder System?

The FDA product code for Aequalis Flex Revive Shoulder System is KWS.

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

K260721Tornier Perform Advanced Glenoid K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K230352Tornier Humeral Nail and Tornier Long Humeral Nail K220914Tornier Perform Humeral System – Fracture K220418Tornier Perform Humeral System – Stemless

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Dispositivos Relacionados (Código: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084Sistema de Ombro AETOS - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416Prótese Metacôndila AETOS Shoulder System Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

Fonte oficial

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