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510(k) K190227

Boomerang™ Anterior Cervical Plate System by Choicespine, LP — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2019
Date Received
February 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Choicespine, LP

  • K183397 — ChoiceSpine Stealth Cervical Spacer System (March 6, 2019)
  • K183588 — Choice Spine Hawkeye Vertebral Body Replacement (VBR) System (February 22, 2019)
  • K182721 — Choice Spine Navigation System (January 8, 2019)
  • K183214 — Raven Lumbar Plate System (January 3, 2019)
  • K180519 — HARRIER-SA™ Lumbar Interbody System (May 16, 2018)
  • K172816 — TiGer Shark™ System (January 26, 2018)
  • K173215 — Choice Spine Laminoplasty™ Fixation System (January 19, 2018)
  • K171489 — Acapella Cervical Spacer System (October 23, 2017)
  • K171686 — Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (September 15, 2017)
  • K171456 — Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (August 3, 2017)

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