Ensemble CMC Implant, Size 151

• FDA 510(k) K201072 decided 2 Dec 2020 Active
• FDA GUDID UDI-DI 00810063560010 listed 30 Mar 2021 Listed

1. 2 Dec 2020 Cleared FDA 510(k) K201072
2. 30 Mar 2021 Listed FDA GUDID 00810063560010

Trade name

Ensemble CMC

Generic name

Metacarpal prosthesis

Model / Ref / Catalog

Ensemble CMC Implant, Size 151, 101-CMC-151

Primary DI / UDI-DI

00810063560010

510(k) Number

K201072 ↗

FDA product code

KYI

GMDN term

Metacarpal prosthesis

Device class

Class II

Regulation number

888.3770

GUDID distribution status

In Commercial Distribution

Category: Metacarpal prosthesis

Other devices filed under FDA product code KYI (Prosthesis, Wrist, Carpal Trapezium).

• ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 by Ascension Orthopedics, Inc.
• Stablyx CMC Arthroplasty Implant System by SKELETAL DYNAMICS, INC
• SPINE ALIGN by B.H. Richardson, D.C.
• RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT by Biologically Oriented Prostheses
• ASCENSION NUGRIP CMC IMPLANT by Ascension Orthopedic
• AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT by Avanta Orthopaedics, Inc.
• NEXA CARPO METACARPAL IMPLANT by Nexa Orthopedics, Inc.
• CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) by Wrightmedicaltechnologyinc
• ARTELON SPACER CMC-1 by Artimplant AB
• STRICKLAND TRAPEZIAL IMPLANT by Wrightmedicaltechnologyinc

• Ensemble CMC Ensemble Instrument Tray

  Class II

  FDA 510(k) K201072 Active Cleared 2 Dec 2020 GUDID on market

• Ensemble CMC Implant, Size 161

  Class II

  FDA 510(k) K201072 Active Cleared 2 Dec 2020 GUDID on market

• Ensemble CMC Implant, Size 141

  Class II

  FDA 510(k) K201072 Active Cleared 2 Dec 2020 GUDID on market

• Ensemble CMC Implant Holder

  Class II

  FDA 510(k) K201072 Active Cleared 2 Dec 2020 GUDID on market

See all devices from Ensemble Orthopedics, LLC →