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510(k) K153107

Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System by Choicespine, LP — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2016
Date Received
October 27, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Choicespine, LP

  • K190227 — Boomerang™ Anterior Cervical Plate System (May 1, 2019)
  • 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)

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