FDA 510(k)

Prime and DYNASTY® Additive Manufacturing Shells

Numéro K : K202705 · 2021-08-20

Date de décision2021-08-20

Code produitOQG

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Prime and DYNASTY® Additive Manufacturing Shells is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K202705. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Prime and DYNASTY® Additive Manufacturing Shells?

Prime and DYNASTY® Additive Manufacturing Shells is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K202705.

When did Prime and DYNASTY® Additive Manufacturing Shells receive FDA 510(k) clearance?

Prime and DYNASTY® Additive Manufacturing Shells received FDA 510(k) clearance on 2021-08-20, under 510(k) number K202705.

Who is the listed applicant for Prime and DYNASTY® Additive Manufacturing Shells?

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

What is the FDA product code for Prime and DYNASTY® Additive Manufacturing Shells?

The FDA product code for Prime and DYNASTY® Additive Manufacturing Shells is OQG.

Essais cliniques associés

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Dispositifs connexes (Code : OQG)

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Source officielle

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