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510(k) K150283

Republic Spine Dark Star Spinal System by Republic Spine, LLC — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2015
Date Received
February 5, 2015
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 Republic Spine, LLC

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  • K190398 — Republic Spine Restore Intervertebral Body Fusion System (September 12, 2019)
  • K190889 — Republic Spine Restore Cervical Interbody Fusion System (June 19, 2019)
  • K181495 — Republic Spine Dark Star Spinal System (July 25, 2018)

Other clearances for product code MNH

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  • 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)