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510(k) K941486

INTEGRITY TOTAL HIP SYSTEM, NON-POROUS by Kirschner Medical Corp. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1994
Date Received
March 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Kirschner Medical Corp.

  • K940537 — KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM (August 29, 1995)
  • K936274 — KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM (January 18, 1995)
  • K942891 — SUMMIT TOTAL HIP SYSTEM (November 2, 1994)
  • K933843 — LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED (August 5, 1994)
  • K935951 — KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM (July 18, 1994)
  • K934589 — KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED (July 13, 1994)
  • K935206 — KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION (July 13, 1994)
  • K934694 — KIRSCHNER ZIRCONIA FEMORAL HEAD (May 18, 1994)
  • K920188 — THREADED PINS (May 12, 1993)
  • K921837 — MEDICAM 900 INSUFFLATOR WITH ACCESSORIES (February 5, 1993)

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