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510(k) K082572

USS ILIOSACRAL, USS POLYAXIAL by Synthes Spine — Product Code NKB

K082572 is an FDA 510(k) premarket notification submitted by Synthes Spine for the device "USS ILIOSACRAL, USS POLYAXIAL". The FDA issued a decision of Substantially Equivalent on November 24, 2008. 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
November 24, 2008
Date Received
September 5, 2008
Clearance Type
Traditional
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)
  • K103287 — SYNTHES 6.0 COCR AND CPT TI-3 RODS (January 5, 2011)

Other clearances for product code NKB

  • K262091 — FRAXION Spinal Fixation System (September 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor (September 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 4, 2026)
  • K253943 — Tiger 2 System (July 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co (July 24, 2026)
  • 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)

FDA data resources