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FDA 510(k)

CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System

Número K: K153374 · 2016-06-17

RequerenteOrthocare
Data da decisão2016-06-17
Código do produtoHRS
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Orthocare. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K153374. 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 CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System?

CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Orthocare. The 510(k) number is K153374.

When did CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System receive FDA 510(k) clearance?

CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System received FDA 510(k) clearance on 2016-06-17, under 510(k) number K153374.

Who is the listed applicant for CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System?

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

What is the FDA product code for CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System?

The FDA product code for CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System is HRS.

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