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510(k) K112607

SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... by Spinevision S.A. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2012
Date Received
September 7, 2011
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 Spinevision S.A.

  • K223251 — Hexanium PLIF (December 16, 2022)
  • K221578 — Hexanium ACIF (November 14, 2022)
  • K210359 — Hexanium TLIF (March 10, 2021)
  • K193000 — Hexanium® ACIF (October 20, 2020)
  • K180437 — Hexanium® TLIF (May 4, 2018)
  • K153783 — SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF (May 4, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K133575 — SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. (June 30, 2014)
  • K130302 — SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISIO (July 30, 2013)

Other clearances for product code NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)