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510(k) K113802

ESCALATE LAMINOPLASTY SYSTEM by Stryker Spine — Product Code NQW

K113802 is an FDA 510(k) premarket notification submitted by Stryker Spine for the device "ESCALATE LAMINOPLASTY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 16, 2012. The device falls under product code NQW (Orthosis, Spine, Plate, Laminoplasty, Metal), a Class II device regulated under 21 CFR 888.3050. Stryker Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2012
Date Received
December 23, 2011
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 Stryker Spine

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioa (April 24, 2026)
  • K242361 — OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal Sy (November 7, 2024)
  • K242280 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioa (August 29, 2024)
  • K222684 — XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serr (June 8, 2023)
  • K221490 — Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Poste (February 14, 2023)
  • K203205 — Navigated Spine Instruments (March 23, 2021)
  • K200666 — Stryker Xia 3 Power Adaptor (April 23, 2020)
  • K183249 — Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curve (July 25, 2019)
  • K183071 — VLIFT-s Vertebral Body Replacement System (January 10, 2019)

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