← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

KWQ — Appliance, Fixation, Spinal Intervertebral Body

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3060
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
19
510(K)/PMA CLEARANCES
510k: 19
0
RECALL ENTRIES

Recent clearances

K261309Bethesda Medical Devices, LLC · 510k2026-07-16
K252776ZheJiang Decans Medical Devices Co., Ltd. · 510k2026-05-14
K261112L&K BIOMED Co., Ltd. · 510k2026-05-06
K260570Carlsmed, Inc. · 510k2026-04-22
K260697Vy Spine, LLC · 510k2026-03-27
K260015SpineCraft · 510k2026-03-04
K251940L&K BIOMED Co., Ltd. · 510k2026-03-03
K254182Osteonic Co., Ltd. · 510k2026-02-26

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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