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510(k) K140678

COSMOLOCK PEDICLE SCREW SYSTEM by Kalitec Direct, LLC — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2014
Date Received
March 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Kalitec Direct, LLC

  • K180401 — TiWAVE-C™ Porous Titanium Cervical Cage (June 14, 2018)
  • K172808 — CosmoLock Pedicle Screw System (October 25, 2017)
  • K172086 — Matira™ Anterior Cervical System (September 22, 2017)
  • K170342 — Ocata Anterior Cervical System (May 9, 2017)
  • K163471 — Kalitec Direct InSePtion™ MIS Fixation System (March 16, 2017)
  • K133815 — INTESS CERVICAL CAGE SYSTEM (April 16, 2014)
  • K123100 — INTESS LUMBAR CAGE (March 28, 2013)
  • K111370 — ODALYS PEDICLE SCREW SYSTEM (September 21, 2011)

Other clearances for product code MNH

  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (November 3, 2016)
  • K162143 — FixxSure® X-Link (September 23, 2016)
  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)