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510(k) K160124

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System by Spinevision S.A. — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2016
Date Received
January 20, 2016
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.

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  • K193000 — Hexanium® ACIF (October 20, 2020)
  • K180437 — Hexanium® TLIF (May 4, 2018)
  • K153783 — SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF (May 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)
  • 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)
  • 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)
  • K152132 — X-spine Pedicle Screw System (September 25, 2015)