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510(k) K173215

Choice Spine Laminoplasty™ Fixation System by Choicespine, LP — Product Code NQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2018
Date Received
October 2, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

Other clearances by Choicespine, LP

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  • K183214 — Raven Lumbar Plate System (January 3, 2019)
  • K180519 — HARRIER-SA™ Lumbar Interbody System (May 16, 2018)
  • K172816 — TiGer Shark™ System (January 26, 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 NQW

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  • K231232 — Curiteva Laminoplasty System (June 28, 2023)
  • K212428 — Centerpiece Plate Fixation System (December 13, 2021)
  • K191927 — Hinged Laminoplasty System (September 20, 2019)
  • K191169 — NuVasive® Camber Laminoplasty System (July 3, 2019)
  • K181717 — Life Spine Laminoplasty System (October 12, 2018)
  • K171413 — HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (July 14, 2017)
  • K160114 — Xspan Laminoplasty Fixation System (March 15, 2016)