KTW · Class II · 21 CFR 888.3030

FDA Product Code KTW: Appliance, Fixation, Nail/blade/plate Combination, Single Component

Leading manufacturers include Synthes (Usa), Orthofix Srl and Advanced Orthopaedic Solutions, Inc..

38
Total
38
Cleared
88d
Avg days
1978
Since
38 devices
25–38 of 38
Cleared Dec 11, 1990
HANSEN-STREET TYPE INTRAMEDULLARY NAIL
K905348
O'Tec Corp.
Orthopedic · 13d
Cleared Nov 03, 1989
LEVTECH SMALL BONE PLATE
K893928
Buckman Co., Inc.
Orthopedic · 156d
Cleared Mar 09, 1987
WARSAW ORTHOPEDIC I BONE PLATE
K870727
Warsaw Orthopedic, Inc.
Orthopedic · 13d
Cleared Sep 02, 1986
ACROMED ADS BONE NAIL
K862552
Buckman Co., Inc.
Orthopedic · 61d
Cleared Jun 03, 1982
ORTHOPEDIC FIXATION DEVICES
K821566
Howmedica Corp.
Orthopedic · 9d
Cleared Dec 06, 1979
SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES
K792291
Synthes (Usa)
Orthopedic · 23d
Cleared Dec 20, 1978
COMPRESSION HIP SCREW SYSTEM
K781762
Howmedica Corp.
Orthopedic · 65d