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510(k) K920188

THREADED PINS by Kirschner Medical Corp. — Product Code MBJ

K920188 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "THREADED PINS". The FDA issued a decision of Substantially Equivalent on May 12, 1993. The device falls under product code MBJ (Fastener, Fixation, Biodegradable, Hard Tissue), a Class III device. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1993
Date Received
January 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Hard Tissue
Device Class
Class III
Regulation Number
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)
  • 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)
  • 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)
  • K921837 — MEDICAM 900 INSUFFLATOR WITH ACCESSORIES (February 5, 1993)

FDA data resources