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FDA PRODUCT CODE · CLASS II

NQW — Orthosis, Spine, Plate, Laminoplasty, Metal

This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3050
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K252930ZheJiang Decans Medical Devices Co., Ltd. · 510k2026-05-27
K243137Curiteva, Inc. · 510k2024-10-28
K242784Vy Spine, LLC · 510k2024-10-16

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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