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510(k) K121276

NEURO VENTION LAMINPLASTY PLATING SYSTEM by Neurovention, LLC — Product Code NQW

K121276 is an FDA 510(k) premarket notification submitted by Neurovention, LLC for the device "NEURO VENTION LAMINPLASTY PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 29, 2012. The device falls under product code NQW (Orthosis, Spine, Plate, Laminoplasty, Metal), a Class II device regulated under 21 CFR 888.3050. Neurovention, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2012
Date Received
April 27, 2012
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 Neurovention, LLC

  • K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Pl (March 13, 2020)

Other clearances for product code NQW

  • K252930 — AQUA Laminoplasty Systems (May 27, 2026)
  • K243137 — Curiteva Porous PEEK Laminoplasty System (October 28, 2024)
  • 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)

FDA data resources