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510(k) K220953

ChoiceSpine TigerShark™ M, Modular Interbody System by Choice Spine, LLC — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2022
Date Received
April 1, 2022
Clearance Type
Traditional
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 Choice Spine, LLC

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  • K211449 — Triton™ Sacroiliac Joint Fixation System (August 31, 2021)
  • K203311 — ChoiceSpine Blackhawk Ti Cervical Spacer System (May 10, 2021)
  • K203561 — ChoiceSpine Navigation System (January 4, 2021)
  • K201643 — ChoiceSpine Tiger Shark Cervical Spacer System (December 22, 2020)
  • K191621 — ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody S (August 15, 2019)
  • K191367 — Harrier-SA Lumbar Interbody System (July 5, 2019)
  • K091531 — CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SP (November 2, 2009)

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