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510(k) K183588

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System by Choicespine — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2019
Date Received
December 21, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Choicespine

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  • K183397 — ChoiceSpine Stealth Cervical Spacer System (March 6, 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)

Other clearances for product code MQP

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  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • K231134 — VerteLoc Spinal System (February 13, 2024)
  • K232173 — Ascend VBR System, Ascend NanoTec VBR System (October 6, 2023)
  • K211892 — ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (October 6, 2022)
  • K202637 — F3D Corpectomy System (December 23, 2020)
  • K200235 — KONG-TL VBR System, KONG-C VBR System (May 29, 2020)
  • K193506 — NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable (February 26, 2020)