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510(k) K130302

SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT by Spinevision S.A. — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2013
Date Received
February 7, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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)
  • K112607 — SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEV (June 7, 2012)

Other clearances for product code MNI

  • K171497 — Mikron Spinal Fixation System (October 12, 2017)
  • K160731 — LumFix Spinal Fixation Sytem (October 4, 2016)
  • K151458 — Double Medical Universal Spine System (August 22, 2016)
  • K153273 — MySpine Pedicle Screw Placement Guides - LP (June 29, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K160320 — Premier (April 1, 2016)
  • K160003 — Sniper (R) Spine System (February 26, 2016)
  • K152324 — YAHUA Spinal System (February 1, 2016)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)