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510(k) K130830

INTEGRA LAMINOPLASTY SYSTEM by Seaspine, Inc. — Product Code NQW

K130830 is an FDA 510(k) premarket notification submitted by Seaspine, Inc. for the device "INTEGRA LAMINOPLASTY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 2013. The device falls under product code NQW (Orthosis, Spine, Plate, Laminoplasty, Metal), a Class II device regulated under 21 CFR 888.3050. Seaspine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2013
Date Received
March 26, 2013
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 Seaspine, Inc.

  • K231654 — NorthStar OCT System (August 3, 2023)
  • K150469 — Integra Laminoplasty System (March 23, 2015)
  • K142488 — SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, C (December 18, 2014)
  • K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM (May 1, 2014)
  • K132859 — INTEGRA FACET FIXATION SYSTEM (November 18, 2013)
  • K121924 — INTEGRA INTERSPINOUS PROCESS SYSTEM (September 4, 2013)
  • K122571 — MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM (December 12, 2012)
  • K112206 — CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (January 25, 2012)
  • K111671 — SEASPINE MONOPOLAR PROBE SYSYEM (December 28, 2011)
  • K102026 — SEASPINE SPACER SYSTEM (May 12, 2011)

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