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510(k) K111370

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

K111370 is an FDA 510(k) premarket notification submitted by Kalitec Direct, LLC for the device "ODALYS PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on September 21, 2011. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Kalitec Direct, LLC has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2011
Date Received
May 16, 2011
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)
  • K140678 — COSMOLOCK PEDICLE SCREW SYSTEM (June 19, 2014)
  • K133815 — INTESS CERVICAL CAGE SYSTEM (April 16, 2014)
  • K123100 — INTESS LUMBAR CAGE (March 28, 2013)

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)

FDA data resources