Device type
Thoracolumbosacral Pedicle Screw System
Product code NKB · Class II · 21 CFR 888.3070 · Orthopedic
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Recent 510(k)s
Oct 29, 2026
K262731
Virata Spinal Fixation System
SeaSpine Orthopedics Corporation
- NKB
- Class II
Oct 2, 2026
K261217
AnyPlus II Spinal Fixation System
GS Medical Co., Ltd.
- NKB
- Class II
Oct 1, 2026
K263062
NOVIX Pedicle Screw System
Tdm Co., Ltd.
- NKB
- Class II
Sep 30, 2026
K262712
Duet™ Spinal Fixation System
Duet Spine Holdings, LLC
- NKB
- Class II
Sep 30, 2026
K263172
SAS MIS Pelvic Incidence Rods
Spinal Alignment Solutions, Inc.
- NKB
- Class II
Sep 27, 2026
K252139
Kentrospine Viktr-MIS® Pedicle screw system
Rivarp Medical Pvt., Ltd.
- NKB
- Class II
Sep 23, 2026
K262067
iFuse Granite Onyx™ Implant System
SI-BONE, Inc.
- NKB
- Class II
Sep 17, 2026
K262091
FRAXION Spinal Fixation System
Ortler Global Tibbi Gerecler Anonim Sirketi
- NKB
- Class II
Sep 14, 2026
K262193
RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology
Xenix Medical
- NKB
- Class II
Sep 4, 2026
K262828
KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O
- NKB
- Class II
Recent recalls
Sep 30, 2026
Z-3226-2026
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
SEASPINE ORTHOPEDICS CORPORATION
- NKB
- Class II
- Ongoing