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FDA 510(k)

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System

Número K: K222282 · 2022-10-27

RequerenteHospital Equipment Manufacturing Company
Data da decisão2022-10-27
Código do produtoHRS
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Hospital Equipment Manufacturing Company. It received FDA 510(k) clearance on 2022-10-27 under 510(k) number K222282. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System?

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System is a medical device that received FDA 510(k) clearance on 2022-10-27. The listed applicant is Hospital Equipment Manufacturing Company. The 510(k) number is K222282.

When did HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System receive FDA 510(k) clearance?

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System received FDA 510(k) clearance on 2022-10-27, under 510(k) number K222282.

Who is the listed applicant for HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System?

The FDA 510(k) record lists Hospital Equipment Manufacturing Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System?

The FDA product code for HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System is HRS.

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Dispositivos Relacionados (Código: HRS)

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Fonte oficial

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