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FDA 510(k)

OsteoCoil™ Nitinol Compression System (Multiple Component PNs)

Número K: K233567 · 2024-11-22

RequerenteFlower Orthopedics Corporation Dba Conventus Flower Ortho
Data da decisão2024-11-22
Código do produtoHWC
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

OsteoCoil™ Nitinol Compression System (Multiple Component PNs) is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation Dba Conventus Flower Ortho. It received FDA 510(k) clearance on 2024-11-22 under 510(k) number K233567. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OsteoCoil™ Nitinol Compression System (Multiple Component PNs)?

OsteoCoil™ Nitinol Compression System (Multiple Component PNs) is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Flower Orthopedics Corporation Dba Conventus Flower Ortho. The 510(k) number is K233567.

When did OsteoCoil™ Nitinol Compression System (Multiple Component PNs) receive FDA 510(k) clearance?

OsteoCoil™ Nitinol Compression System (Multiple Component PNs) received FDA 510(k) clearance on 2024-11-22, under 510(k) number K233567.

Who is the listed applicant for OsteoCoil™ Nitinol Compression System (Multiple Component PNs)?

The FDA 510(k) record lists Flower Orthopedics Corporation Dba Conventus Flower Ortho as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoCoil™ Nitinol Compression System (Multiple Component PNs)?

The FDA product code for OsteoCoil™ Nitinol Compression System (Multiple Component PNs) is HWC. This falls under the Cardiovascular category.

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