FDA 510(k)

ICONN Campbell Interference Screw

Número K: K180670 · 2018-12-07

Data da decisão2018-12-07

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ICONN Campbell Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Iconn Orthopedics, LLC. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K180670. 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 ICONN Campbell Interference Screw?

ICONN Campbell Interference Screw is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Iconn Orthopedics, LLC. The 510(k) number is K180670.

When did ICONN Campbell Interference Screw receive FDA 510(k) clearance?

ICONN Campbell Interference Screw received FDA 510(k) clearance on 2018-12-07, under 510(k) number K180670.

Who is the listed applicant for ICONN Campbell Interference Screw?

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

What is the FDA product code for ICONN Campbell Interference Screw?

The FDA product code for ICONN Campbell Interference Screw is HWC. This falls under the Cardiovascular category.

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Fonte oficial

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