Home / 510(k) Clearances / K103287

510(k) K103287

SYNTHES 6.0 COCR AND CPT TI-3 RODS by Synthes Spine — Product Code NKB

K103287 is an FDA 510(k) premarket notification submitted by Synthes Spine for the device "SYNTHES 6.0 COCR AND CPT TI-3 RODS". The FDA issued a decision of Substantially Equivalent on January 5, 2011. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Synthes Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2011
Date Received
November 1, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Synthes Spine

  • K122211 — SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS (December 17, 2012)
  • K120838 — SYNTHES MATRIX SYSTEM (July 31, 2012)
  • K111048 — SYNTHES SCOUT TACK FIXATION (June 14, 2012)
  • K120928 — SYNTHES MATRIX SYSTEM (May 18, 2012)
  • K120571 — SYNTHES USS CONNECTOR (May 14, 2012)
  • K113149 — SYNTHES USS CONNECTORS (February 1, 2012)
  • K113044 — SYNTHES MIRS (December 21, 2011)
  • K111358 — SYNTHES USS (November 18, 2011)
  • K103558 — SYNTHES SCOUT VESSEL GUARD (February 18, 2011)
  • K093762 — SYNTHES ZERO-P (December 20, 2010)

Other clearances for product code NKB

  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)

FDA data resources