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510(k) K954856

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

K954856 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "CANNULATED FEMORAL NAIL". The FDA issued a decision of Substantially Equivalent on March 8, 1996. The device falls under product code JDN (Implant, Fixation Device, Spinal), a Class II device regulated under 21 CFR 888.3060. Synthes (Usa) has at least 10 other 510(k) clearances on record.

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

Other clearances by Synthes (Usa)

  • K180821 — TruMatch Graft Cage - Long Bone (December 21, 2018)
  • K152239 — Zero-P Natural Plate System (December 2, 2015)
  • K131984 — SYNTHES SYNSONIC ULNA NAIL (March 31, 2014)
  • K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (May 20, 2013)
  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)

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)

FDA data resources