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510(k) K792186

HOWMEDICA MIX-KIT II by Howmedica Corp. — Product Code JDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1979
Date Received
October 31, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Cement, For Clinical Use
Device Class
Class I
Regulation Number
888.4210
Review Panel
OR
Submission Type

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  • K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (January 29, 1999)
  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
  • K983404 — TYPE 3 FEMORAL COMPONENTS (December 22, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)

Other clearances for product code JDZ

  • K934253 — EXACTECH ALL POLY ACETABULAR CUP (April 29, 1994)
  • K925025 — PRISM BONE CEMENT MIXING SYSTEM (January 5, 1994)
  • K912190 — STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST (August 29, 1991)
  • K892937 — REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS (June 22, 1989)
  • K861086 — ZIMMER VACUUM MIXING SYSTEM (April 14, 1986)
  • K854077 — MIX EVAC II (January 31, 1986)
  • K853310 — SIMPLEX ENHANCEMENT MIXER (September 11, 1985)
  • K851205 — CEMENTRIFUGE (July 16, 1985)
  • K843219 — ZIMMER BONE CEMENT CENTRIFUGATION SYS (November 29, 1984)
  • K780857 — MIXING BOWL & SPATULA, DISPOSABLE (June 13, 1978)