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510(k) K954856

CANNULATED FEMORAL NAIL by Synthes (Usa) — Product Code JDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1996
Date Received
October 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Fixation Device, Spinal
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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Other clearances for product code JDN

  • K897141 — SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO (June 21, 1990)
  • K894184 — BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM (April 25, 1990)
  • K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY (December 7, 1987)
  • K873977 — NEW C-D SYSTEM FOR SPINAL SURGERY (December 7, 1987)
  • K760649 — TOTAL SPINAL CORRECTION (October 5, 1976)