FDA 510(k) Applications for Medical Device Product Code "KYI"
(Prosthesis, Wrist, Carpal Trapezium)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K061954 |
ARTIMPLANT AB |
ARTELON CMC SPACER ARTHRO |
06/01/2007 |
K040070 |
ARTIMPLANT AB |
ARTELON SPACER CMC-1 |
09/21/2004 |
K061956 |
ARTIMPLANT AB |
ARTELON STT SPACER |
06/07/2007 |
K112278 |
ASCENSION ORTHOPEDIC |
ASCENSION NUGRIP CMC IMPLANT |
11/04/2011 |
K041451 |
ASCENSION ORTHOPEDICS, INC. |
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 |
08/25/2004 |
K042690 |
ASCENSION ORTHOPEDICS, INC. |
ASCENSION PYROSPHERE (PCS) |
11/13/2004 |
K061451 |
ASCENSION ORTHOPEDICS, INC. |
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 |
08/11/2006 |
K964381 |
AVANTA ORTHOPAEDICS, INC. |
AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT |
01/22/1997 |
K965204 |
AVANTA ORTHOPAEDICS, INC. |
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT |
06/03/1997 |
K964472 |
BIOLOGICALLY ORIENTED PROSTHESES |
RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT |
02/03/1997 |
K052596 |
BIOPRO, INC. |
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 |
11/15/2005 |
K061089 |
BIOPRO, INC. |
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 |
06/20/2006 |
K201072 |
Ensemble Orthopedics, LLC |
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 |
12/02/2020 |
K092548 |
EXTREMITY MEDICAL LLC |
EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS |
12/15/2009 |
K060386 |
NEXA ORTHOPEDICS, INC. |
NEXA CARPO METACARPAL IMPLANT |
05/10/2006 |
K111068 |
SKELETAL DYNAMICS, LLC |
STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 |
12/30/2011 |
K180744 |
Skeletal Dynamics, LLC |
Stablyx CMC Arthroplasty Implant System |
04/11/2018 |
K960659 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) |
02/06/1997 |
K960534 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
METALLIC SPHERICAL CMC IMPLANT |
02/06/1997 |
K033529 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
TIE-IN TRAPEZIUM |
12/03/2003 |
|
|