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510(k) K924379

ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM by Johnson & Johnson Orthopaedics, Inc. — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
August 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Johnson & Johnson Orthopaedics, Inc.

  • K931466 — PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI (December 6, 1994)
  • K935452 — P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT (October 6, 1994)
  • K940190 — ULTIMA UNIPOLAR MODULAR HEAD (September 29, 1994)
  • K933275 — P.F.C. CERAMIC HIP HEAD (September 28, 1994)
  • K932595 — ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR (September 20, 1994)
  • K931655 — P.F.C. BIPOLAR HIP SYSTEM (June 9, 1994)
  • K933867 — UNIVERSAL INSET PATELLA (June 6, 1994)
  • K935262 — P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA (June 3, 1994)
  • K931189 — P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET (February 9, 1994)
  • K931054 — TRICK MODULAR KNEE TIBIAL TRAY-POROUS (January 25, 1994)

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