KWD · Class II · 21 CFR 888.3730

FDA Product Code KWD: Prosthesis, Toe, Hemi-, Phalangeal

Leading manufacturers include Arthrosurface, Inc., Solana Surgical, LLC and Biopro, Inc..

45
Total
45
Cleared
145d
Avg days
1979
Since
45 devices
25–45 of 45
Cleared Nov 12, 2004
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
K041595
Biopro, Inc.
Orthopedic · 151d
Cleared Feb 18, 2004
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
K031859
Arthrosurface, Inc.
Orthopedic · 247d
Cleared Nov 26, 2003
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319
Wrightmedicaltechnologyinc
Orthopedic · 300d
Cleared Dec 12, 2002
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
K023770
Kinetikos Medical, Inc.
Orthopedic · 30d
Cleared Jun 20, 1997
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
K971047
Nexa Orthopedics, Inc.
Orthopedic · 91d
Cleared Nov 22, 1991
TOWNLEY GREAT TOE JOINT
K911378
Biopro, Inc.
Orthopedic · 239d
Cleared Apr 15, 1987
SWANSON TITANIUM GREAT TOE IMPLANT
K864492
Dow Corning Wright
Orthopedic · 153d
Cleared Feb 09, 1979
IMPLANT, H.P. CONDYLAR
K781870
Dow Corning Corp. Healthcare Industries Materials
Orthopedic · 98d