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510(k) K130830

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

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.

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  • K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM (May 1, 2014)
  • K132859 — INTEGRA FACET FIXATION SYSTEM (November 18, 2013)
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  • 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

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  • 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)