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510(k) K912837

MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS by Kirschner Medical Corp. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1992
Date Received
June 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

Other clearances by Kirschner Medical Corp.

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  • K936274 — KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM (January 18, 1995)
  • K942891 — SUMMIT TOTAL HIP SYSTEM (November 2, 1994)
  • K941486 — INTEGRITY TOTAL HIP SYSTEM, NON-POROUS (September 20, 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)
  • K935206 — KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION (July 13, 1994)
  • K934589 — KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED (July 13, 1994)
  • K934694 — KIRSCHNER ZIRCONIA FEMORAL HEAD (May 18, 1994)
  • K920188 — THREADED PINS (May 12, 1993)

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