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510(k) K172206

NAJA™ Ligament Correction System by Cousin Biotech Sas — Product Code OWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2018
Date Received
July 21, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Fixation Cerclage, Sublaminar
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

Other clearances by Cousin Biotech Sas

  • K181086 — Cortical Fixation Systems (January 9, 2019)
  • K181799 — ResCUBE™ Ligament Fixation System (August 29, 2018)
  • K133889 — PREMIUM (September 4, 2014)
  • K093196 — BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 (June 25, 2010)
  • K072962 — CABS'AIR (June 26, 2008)
  • K070918 — 4DDOME (August 22, 2007)

Other clearances for product code OWI

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  • K230565 — HILINE™ Fixation System (April 20, 2023)
  • K213659 — LigaPASS™ 2.0 Ligament Augmentation System (May 24, 2022)
  • K211057 — LigaPASS® Spinal System, CD Horizon™ Spinal System (May 27, 2021)
  • K201240 — Mariner Cap System (August 5, 2020)
  • K200281 — The Gecko Spinal System (March 31, 2020)
  • K200097 — Response BandLoc Spinal Fixation (March 16, 2020)
  • K191217 — JAZZ PF (August 2, 2019)
  • K190289 — Karma® Fixation System (April 3, 2019)
  • K190418 — NuVasive® VersaTie® System (March 21, 2019)