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FDA 510(k)

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate

Número K: K222650 · 2022-12-09

RequerenteStryker Craniomaxillofacial (Cmf)
Data da decisão2022-12-09
Código do produtoJEY
Comité consultivoDE
DecisãoSubstantially Equivalent

Resumo do dispositivo

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Craniomaxillofacial (Cmf). It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222650. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Stryker Craniomaxillofacial (Cmf). The 510(k) number is K222650.

When did Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate receive FDA 510(k) clearance?

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222650.

Who is the listed applicant for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

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

What is the FDA product code for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

The FDA product code for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is JEY.

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