FDA 510(k)

AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip

N.º K: K192750 · 2020-01-16

Fecha de decisión2020-01-16

Código de productoMBI

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip is the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical, LLC. It received FDA 510(k) clearance on 2020-01-16 under 510(k) number K192750. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip?

AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip is a medical device that received FDA 510(k) clearance on 2020-01-16. The listed applicant is Parcus Medical, LLC. The 510(k) number is K192750.

When did AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip receive FDA 510(k) clearance?

AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip received FDA 510(k) clearance on 2020-01-16, under 510(k) number K192750.

Who is the listed applicant for AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip?

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

What is the FDA product code for AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip?

The FDA product code for AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip is MBI.

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Otros registros que enlistan a Parcus Medical, LLC como solicitante

K221502Parcus Synd-EZ SS K221135X-Twist PEEK Suture Anchor K212739ActiFlip K202662Parcus Titanium Interference Screws K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors

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Fuente oficial

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