KYI · Class II · 21 CFR 888.3770

FDA Product Code KYI: Prosthesis, Wrist, Carpal Trapezium

Leading manufacturers include Wrightmedicaltechnologyinc, Ensemble Orthopedics, LLC and Skeletal Dynamics, LLC.

26
Total
26
Cleared
139d
Avg days
1978
Since

FDA 510(k) Cleared Prosthesis, Wrist, Carpal Trapezium Devices (Product Code KYI)

26 devices
1–24 of 26
Cleared Dec 02, 2020
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
K201072
Ensemble Orthopedics, LLC
Orthopedic · 224d
Cleared Apr 11, 2018
Stablyx CMC Arthroplasty Implant System
K180744
Skeletal Dynamics, LLC
Orthopedic · 20d
Cleared Dec 03, 2003
TIE-IN TRAPEZIUM
K033529
Wrightmedicaltechnologyinc
Orthopedic · 23d
Cleared Feb 06, 1997
METALLIC SPHERICAL CMC IMPLANT
K960534
Wrightmedicaltechnologyinc
Orthopedic · 365d
Cleared Feb 06, 1997
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
K960659
Wrightmedicaltechnologyinc
Orthopedic · 356d
Cleared Aug 09, 1995
STRICKLAND TRAPEZIAL IMPLANT
K951471
Wrightmedicaltechnologyinc
Orthopedic · 132d

About Product Code KYI - Regulatory Context