KWN · Class II · 21 CFR 888.3750

FDA Product Code KWN: Prosthesis, Wrist, Carpal Lunate

Leading manufacturers include Biomet Manufacturing, Inc., Ascension Orthopedics, Inc. and Arthrosurface, Inc..

5
Total
5
Cleared
104d
Avg days
1979
Since

FDA 510(k) Cleared Prosthesis, Wrist, Carpal Lunate Devices (Product Code KWN)

5 devices
1–5 of 5
Cleared Dec 23, 2014
Wrist Hemiarthroplasty System
K141920
Arthrosurface, Inc.
Orthopedic · 160d
Cleared Jun 17, 2008
ASCENSION PYROCARBON LUNATE
K080997
Ascension Orthopedics, Inc.
Orthopedic · 70d
Cleared Mar 25, 2005
MAESTRO CARPAL HEMIARTHROPLASTY
K050028
Biomet Manufacturing, Inc.
Orthopedic · 78d
Cleared Apr 15, 1987
SWANSON TITANIUM CARPAL LUNATE IMPLANT
K864491
Dow Corning Wright
Orthopedic · 153d
Cleared Jun 22, 1979
AMC R METACARPAL COMPONENT
K790793
Howmedica Corp.
Orthopedic · 59d

About Product Code KWN - Regulatory Context