← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
NKB — Thoracolumbosacral Pedicle Screw System
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
DEVICE CLASS
Class II
REGULATION
21 CFR 888.3070
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
55
510(K)/PMA CLEARANCES
510k: 55
0
RECALL ENTRIES
Recent clearances
K261284Alphatec Spine, Inc. · 510k2026-07-14
K253802S.M.A.I.O · 510k2026-07-01
K253045Socko Medical Co., Ltd. · 510k2026-06-17
K251251Chanpin Medtak Co., Ltd. · 510k2026-06-09
K260989Kyocera Medical Technologies Inc. (KMTI) · 510k2026-05-15
K253739Globus Medical, Inc. · 510k2026-05-07
K261130L&K BIOMED Co., Ltd. · 510k2026-05-05
K253966Spineart SA · 510k2026-05-01
Related on SPEQ
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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