FDA 510(k)

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

K-Nummer: K201660 · 2020-07-16

AntragstellerKyocera Medical Technologies, Inc.

Entscheidungsdatum2020-07-16

ProduktcodeOQG

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K201660. 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 KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K201660.

When did KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System receive FDA 510(k) clearance?

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System received FDA 510(k) clearance on 2020-07-16, under 510(k) number K201660.

Who is the listed applicant for KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

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

What is the FDA product code for KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

The FDA product code for KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is OQG.

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Weitere Einträge mit Kyocera Medical Technologies, Inc. als Antragsteller

K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System K242928Tesera-k SC System K242045Initia T3 Acetabular Hemispherical Shell System K242771Tesera-k PL System and Tesera-k XL System K243295Initia Knee System K243015Skyway Anterior Cervical Plate System

Alle 16 Geräte anzeigen →

Verwandte Geräte (Code: OQG)

K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.K203472KMTI Hip Replacement 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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