FDA 510(k)

Ancre sans noeud GRYPHON™ Flex 2.7 mm PEEK; Ancre en biocomposite sans noeud GRYPHON™ Flex 2.7 mm

Numéro K : K232492 · 2023-10-06

Date de décision2023-10-06

Code produitMBI

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232492. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor?

2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Medos International SARL. The 510(k) number is K232492.

When did 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor receive FDA 510(k) clearance?

2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232492.

Who is the listed applicant for 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor?

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

What is the FDA product code for 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor?

The FDA product code for 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor is MBI.

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Source officielle

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