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510(k) K831076

COMPRESSION SYSTEM by Kirschner Medical Corp. — Product Code JDO

K831076 is an FDA 510(k) premarket notification submitted by Kirschner Medical Corp. for the device "COMPRESSION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. Kirschner Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1983
Date Received
April 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Proximal Femoral, Implant
Device Class
Class II
Regulation Number
888.3030
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)
  • K920188 — THREADED PINS (May 12, 1993)

Other clearances for product code JDO

  • K230764 — OsteoCentric Integrated Hip Fastener System (April 18, 2023)
  • K213126 — Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, V (September 29, 2022)
  • K210247 — OsteoCentric Integrated Hip Fastener System (April 30, 2021)
  • K193029 — CONQUEST FN (February 28, 2020)
  • K173826 — THP Hip Fracture Plating System (February 7, 2018)
  • K172785 — CONQUEST FN (December 22, 2017)
  • K152686 — CONQUEST FN (March 17, 2016)
  • K140018 — TSP HIP FRACTURE PLATING SYSTEM (April 4, 2014)
  • K080685 — HIPLOC COMPRESSION HIP SCREW (August 15, 2008)
  • K080434 — INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (April 10, 2008)

FDA data resources