FDA 510(k)

STROPP (Single Tunnel Repair of Plantar Plate)

Número K: K160118 · 2016-05-03

RequerenteCrossroads Extremity Systems, LLC

Data da decisão2016-05-03

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

STROPP (Single Tunnel Repair of Plantar Plate) is the device name listed in this FDA 510(k) record. The listed applicant is Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2016-05-03 under 510(k) number K160118. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STROPP (Single Tunnel Repair of Plantar Plate)?

STROPP (Single Tunnel Repair of Plantar Plate) is a medical device that received FDA 510(k) clearance on 2016-05-03. The listed applicant is Crossroads Extremity Systems, LLC. The 510(k) number is K160118.

When did STROPP (Single Tunnel Repair of Plantar Plate) receive FDA 510(k) clearance?

STROPP (Single Tunnel Repair of Plantar Plate) received FDA 510(k) clearance on 2016-05-03, under 510(k) number K160118.

Who is the listed applicant for STROPP (Single Tunnel Repair of Plantar Plate)?

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

What is the FDA product code for STROPP (Single Tunnel Repair of Plantar Plate)?

The FDA product code for STROPP (Single Tunnel Repair of Plantar Plate) is MBI.

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