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510(k) K210359

Hexanium TLIF by Spinevision, S.A.S. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2021
Date Received
February 8, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Spinevision, S.A.S.

  • K223251 — Hexanium PLIF (December 16, 2022)
  • K221578 — Hexanium ACIF (November 14, 2022)
  • 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)
  • K112607 — SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEV (June 7, 2012)

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