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510(k) K897141

SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO by Stuart — Product Code JDN

K897141 is an FDA 510(k) premarket notification submitted by Stuart for the device "SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO". The FDA issued a decision of SN on June 21, 1990. The device falls under product code JDN (Implant, Fixation Device, Spinal), a Class II device regulated under 21 CFR 888.3060. Stuart has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
June 21, 1990
Date Received
December 27, 1989
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 Stuart

  • K890601 — STUART TITANIUM SURGICAL MESH (March 16, 1989)
  • K851414 — SEGMENTAL SPINAL RODS (June 28, 1985)
  • K843445 — SACRAL BAR (February 13, 1985)
  • K820034 — ANTERIOR DISTRACTION SYSTEM (March 11, 1982)

Other clearances for product code JDN

  • K954856 — CANNULATED FEMORAL NAIL (March 8, 1996)
  • 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