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510(k) K853310

SIMPLEX ENHANCEMENT MIXER by Howmedica Corp. — Product Code JDZ

K853310 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "SIMPLEX ENHANCEMENT MIXER". The FDA issued a decision of Substantially Equivalent on September 11, 1985. The device falls under product code JDZ (Mixer, Cement, For Clinical Use), a Class I device regulated under 21 CFR 888.4210. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1985
Date Received
August 7, 1985
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

Other clearances by Howmedica Corp.

  • K984251 — XIA SPINE SYSTEM (February 24, 1999)
  • K984202 — HOWMEDICA HUMERAL INTERCALARY SYSTEM (February 5, 1999)
  • K984305 — ZETA MULTIZONE LOCKING NAIL SYSTEM (February 1, 1999)
  • K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (January 29, 1999)
  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
  • K983404 — TYPE 3 FEMORAL COMPONENTS (December 22, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - 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)
  • K851205 — CEMENTRIFUGE (July 16, 1985)
  • K843219 — ZIMMER BONE CEMENT CENTRIFUGATION SYS (November 29, 1984)
  • K792186 — HOWMEDICA MIX-KIT II (December 5, 1979)
  • K780857 — MIXING BOWL & SPATULA, DISPOSABLE (June 13, 1978)

FDA data resources