FDA 510(k)

Prime and DYNASTY® Additive Manufacturing Shells

K-Nummer: K202705 · 2021-08-20

AntragstellerMicroport Orthopedics, Inc.

Entscheidungsdatum2021-08-20

ProduktcodeOQG

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Weitere Einträge mit Microport Orthopedics, Inc. als Antragsteller

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Verwandte Geräte (Code: OQG)

K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.K172651FMP Extended LinersEncore Medical L.P.K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint Orthopedics, Inc.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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