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510(k) K243137

Curiteva Porous PEEK Laminoplasty System by Curiteva, Inc. — Product Code NQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2024
Date Received
September 30, 2024
Clearance Type
Special
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 Curiteva, Inc.

  • K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte (January 16, 2026)
  • K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System (January 15, 2026)
  • K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
  • K233360 — Curiteva Thoracolumbar Plate System (February 29, 2024)
  • K233744 — Curiteva Porous PEEK Lumbar Interbody Fusion System (January 18, 2024)
  • K231232 — Curiteva Laminoplasty System (June 28, 2023)
  • K213030 — Curiteva Porous PEEK Cervical Interbody Fusion System (February 13, 2023)
  • K223200 — Curiteva Navigation System (January 6, 2023)
  • K210402 — Curiteva Sacroiliac Joint Fusion System (September 9, 2021)
  • K191810 — Curiteva Pedicle Screw System (August 28, 2019)

Other clearances for product code NQW

  • K242784 — Vy Spine™ VyLam™ Laminoplasty System (October 16, 2024)
  • K232471 — Vy Spine™ VyLam™ Laminoplasty System (October 10, 2023)
  • 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)
  • K173215 — Choice Spine Laminoplasty™ Fixation System (January 19, 2018)
  • K171413 — HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (July 14, 2017)
  • K160114 — Xspan Laminoplasty Fixation System (March 15, 2016)