FDA 510(k)

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

Número K: K213328 · 2022-02-11

Data da decisão2022-02-11

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K213328. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Stryker GmbH. The 510(k) number is K213328.

When did Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System receive FDA 510(k) clearance?

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System received FDA 510(k) clearance on 2022-02-11, under 510(k) number K213328.

Who is the listed applicant for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

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

What is the FDA product code for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System?

The FDA product code for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System is HSB.

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Outros registros que listam Stryker GmbH como candidato(a)

K261481Pangea Femur Reconstruction System K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System K253202Hoffmann LRF System K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System K250163Sistema de Nalga Retrograda T2 Alpha do Fêmur K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

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Fonte oficial

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