JDZ · Class I · 21 CFR 888.4210

FDA Product Code JDZ: Mixer, Cement, For Clinical Use

Leading manufacturers include Stryker Corp., Howmedica Corp. and Zimmer, Inc..

13
Total
13
Cleared
105d
Avg days
1976
Since

FDA 510(k) Cleared Mixer, Cement, For Clinical Use Devices (Product Code JDZ)

13 devices
1–13 of 13
Cleared Apr 29, 1994
EXACTECH ALL POLY ACETABULAR CUP
K934253
Exactech, Inc.
Orthopedic · 241d
Cleared Jan 05, 1994
PRISM BONE CEMENT MIXING SYSTEM
K925025
Depuy, Inc.
Orthopedic · 460d
Cleared Aug 29, 1991
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
K912190
Stryker Corp.
Orthopedic · 104d
Cleared Jun 22, 1989
REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
K892937
Dentsply Intl.
Orthopedic · 62d
Cleared Apr 14, 1986
ZIMMER VACUUM MIXING SYSTEM
K861086
Zimmer, Inc.
Orthopedic · 24d
Cleared Jan 31, 1986
MIX EVAC II
K854077
Stryker Corp.
Orthopedic · 116d
Cleared Sep 11, 1985
SIMPLEX ENHANCEMENT MIXER
K853310
Howmedica Corp.
Orthopedic · 35d
Cleared Nov 29, 1984
ZIMMER BONE CEMENT CENTRIFUGATION SYS
K843219
Zimmer, Inc.
Orthopedic · 106d
Cleared Dec 05, 1979
HOWMEDICA MIX-KIT II
K792186
Howmedica Corp.
Orthopedic · 35d
Cleared Jun 13, 1978
MIXING BOWL & SPATULA, DISPOSABLE
K780857
Howmedica Corp.
Orthopedic · 20d
Cleared Oct 05, 1976
MIX EVAC BONE CEMENT
K760617
Stryker Corp.
Orthopedic · 22d

About Product Code JDZ - Regulatory Context