JEC · Class II · 21 CFR 888.3040

FDA Product Code JEC: Component, Traction, Invasive

Leading manufacturers include Howmedica Corp., Ace Orthopedic Manufacturing Co. and Hand Biomechanics Lab, Inc..

85
Total
85
Cleared
96d
Avg days
1976
Since
85 devices
73–85 of 85
Cleared Nov 19, 1980
EXTENDED BALLJOINT GRIP
K802723
Howmedica Corp.
Orthopedic · 19d
Cleared Nov 19, 1980
HOFFMAN LEG LENGTHENING DEVICE
K802776
Howmedica Corp.
Orthopedic · 14d
Cleared Feb 11, 1980
OXFORD EXTERNAL FIXATION SYSTEM
K800184
Downs Surgical , Ltd.
Orthopedic · 13d
Cleared Dec 19, 1979
MINI-H-FIXATION
K792561
Geny Medical, Inc.
Orthopedic · 7d
Cleared Aug 16, 1979
ACE EXTERNAL BONE CLAMP PART #S11
K791466
Ace Orthopedic Manufacturing Co.
Orthopedic · 15d
Cleared Feb 13, 1979
UNIVERSAL EXTERNAL FIXATION ASSEMBLY
K790262
Zimmer, Inc.
Orthopedic · 7d
Cleared Nov 08, 1978
BONE CLAMP, ACE EXTERNAL
K781839
Ace Orthopedic Manufacturing Co.
Orthopedic · 12d
Cleared Nov 08, 1978
EXTERNAL ARTICULATION
K781840
Ace Orthopedic Manufacturing Co.
Orthopedic · 12d
Cleared Nov 08, 1978
BAR, DISTRACTION
K781841
Ace Orthopedic Manufacturing Co.
Orthopedic · 12d
Cleared Nov 03, 1978
FRAME, UNIVERSAL DAY
K781793
B.G. Orthopedic Corp.
Orthopedic · 9d
Cleared Mar 30, 1977
TIBIAL COMPRESSION FRAM FOR FRACTURES
K770066
Richard F. Kronner, M.D.
Orthopedic · 77d
Cleared Mar 14, 1977
FRACTURE REDUCTION SYS., MODEL OR 1001
K770388
Sisan Assoc.
Orthopedic · 14d
Cleared Dec 17, 1976
DEPUY MODIFIED SKELETAL TRACTION PIN
K761088
Depuy, Inc.
Orthopedic · 25d