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510(k) K122822

SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM by Spectrum Spine, LLC — Product Code NQW

K122822 is an FDA 510(k) premarket notification submitted by Spectrum Spine, LLC for the device "SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 7, 2013. The device falls under product code NQW (Orthosis, Spine, Plate, Laminoplasty, Metal), a Class II device regulated under 21 CFR 888.3050. Spectrum Spine, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2013
Date Received
September 14, 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 Spectrum Spine, LLC

  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
  • K243074 — Spectrum Spine Lumbar Cage System (April 4, 2025)
  • K240838 — Spectrum Spine Cervical Cage System (May 30, 2024)
  • K201024 — Expandable Titanium PLIF/TLIF System (April 29, 2021)
  • K173518 — Spectrum Spine Expandable Cages (SSEC) (March 7, 2019)
  • K132126 — SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM (October 28, 2013)

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