FDA 510(k)

Sonoma Fifth Metatarsal Repair System

Numéro K : K161371 · 2017-02-24

DemandeurSonoma Orthopedic Products, Inc.

Date de décision2017-02-24

Code produitHSB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Sonoma Fifth Metatarsal Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Orthopedic Products, Inc.. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K161371. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sonoma Fifth Metatarsal Repair System?

Sonoma Fifth Metatarsal Repair System is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Sonoma Orthopedic Products, Inc.. The 510(k) number is K161371.

When did Sonoma Fifth Metatarsal Repair System receive FDA 510(k) clearance?

Sonoma Fifth Metatarsal Repair System received FDA 510(k) clearance on 2017-02-24, under 510(k) number K161371.

Who is the listed applicant for Sonoma Fifth Metatarsal Repair System?

The FDA 510(k) record lists Sonoma Orthopedic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonoma Fifth Metatarsal Repair System?

The FDA product code for Sonoma Fifth Metatarsal Repair System is HSB.

Essais cliniques associés

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Source officielle

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