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510(k) K925025

PRISM BONE CEMENT MIXING SYSTEM by Depuy, Inc. — Product Code JDZ

K925025 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "PRISM BONE CEMENT MIXING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 5, 1994. The device falls under product code JDZ (Mixer, Cement, For Clinical Use), a Class I device regulated under 21 CFR 888.4210. Depuy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1994
Date Received
October 2, 1992
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 Depuy, Inc.

  • K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS (March 14, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
  • K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (July 22, 2004)
  • K033959 — LPS (July 1, 2004)
  • K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO (May 28, 2004)
  • K021478 — DELTA SHOULDER (November 18, 2003)
  • K033329 — DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (November 14, 2003)
  • K032151 — DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (September 26, 2003)
  • K020541 — AGILITY ANKLE REVISION PROSTHESIS (May 20, 2002)
  • K011810 — ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (September 7, 2001)

Other clearances for product code JDZ

  • K934253 — EXACTECH ALL POLY ACETABULAR CUP (April 29, 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)
  • K792186 — HOWMEDICA MIX-KIT II (December 5, 1979)
  • K780857 — MIXING BOWL & SPATULA, DISPOSABLE (June 13, 1978)

FDA data resources