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510(k) K252930

AQUA Laminoplasty Systems by ZheJiang Decans Medical Devices Co., Ltd. — Product Code NQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2026
Date Received
September 15, 2025
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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  • K191927 — Hinged Laminoplasty System (September 20, 2019)
  • K191169 — NuVasive® Camber Laminoplasty System (July 3, 2019)
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  • K173215 — Choice Spine Laminoplasty™ Fixation System (January 19, 2018)
  • K171413 — HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (July 14, 2017)