KIH · Class I · 21 CFR 888.4200

FDA Product Code KIH: Dispenser, Cement

Leading manufacturers include Howmedica Corp., Dentsply Intl. and Johnson & Johnson Professionals, Inc..

11
Total
11
Cleared
42d
Avg days
1978
Since

FDA 510(k) Cleared Dispenser, Cement Devices (Product Code KIH)

11 devices
1–11 of 11
Cleared Oct 22, 2004
SMARTMIX PRE-FILLED MIXING SYSTEM
K042591
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Dec 21, 1994
P.F.C. CEMENT PRESSURIZING SYSTEM
K943906
Johnson & Johnson Professionals, Inc.
Orthopedic · 132d
Cleared Mar 02, 1990
CMW CEMENT PRESSURISATION SYSTEM
K897134
Dentsply Intl.
Orthopedic · 65d
Cleared Jun 13, 1985
ORTHOPEADIC CEMENT DELIVERY SYSTEM
K851881
Dentsply Intl.
Orthopedic · 45d
Cleared Dec 12, 1983
BRIGHAM TIBIAL CEMENT PRESSURIZER
K833675
Howmedica Corp.
Orthopedic · 55d
Cleared May 29, 1981
HOWMEDICA FEMORAL PRESSURING SEAL
K811317
Howmedica Corp.
Orthopedic · 17d
Cleared Jul 28, 1980
OH-HARRIS
K801388
Johnson & Johnson Professionals, Inc.
Orthopedic · 45d
Cleared Feb 21, 1979
GUN, EXETER CEMENT
K790275
Howmedica Corp.
Orthopedic · 12d
Cleared Dec 04, 1978
GUN, CEMENT
K781955
Depuy, Inc.
Orthopedic · 13d
Cleared Feb 28, 1978
BONE CEMENT APPLICATOR
K780266
Zimmer, Inc.
Orthopedic · 11d

About Product Code KIH - Regulatory Context