Swedge™ Pedicle Screw Fixation System Bezier Rod

FDA 510(k) K252461 · Spinal Resources, Inc.

Substantially Equivalent

510(k) numberK252461

Submission

Device name
Swedge™ Pedicle Screw Fixation System Bezier Rod
Applicant
Spinal Resources, Inc.
Fort Lauderdale, FL, US
Received
August 5, 2025
Decision date
January 13, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NKB – Thoracolumbosacral Pedicle Screw System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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K262828KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special S.M.A.I.O09/04/2026SE
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K253943Tiger 2 SystemNKB · Traditional Zavation Medical Products, LLC07/24/2026SE
K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional Alphatec Spine, Inc.07/14/2026SE
K253802KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special S.M.A.I.O07/01/2026SE
K253045“Socko” Vimax Spinal Fixation SystemNKB · Traditional Socko Medical Co., Ltd.06/17/2026SE
K251251ChanPin Pedicle Screw Spinal SystemNKB · Traditional Chanpin Medtak Co., Ltd.06/09/2026SE
K260989Varion Thoracolumbar Fixation SystemNKB · Traditional Kyocera Medical Technologies Inc. (KMTI)05/15/2026SE
K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional Globus Medical, Inc.05/07/2026SE
K261130AccelFix Spinal Fixation SystemNKB · Special L&K BIOMED Co., Ltd.05/05/2026SE

More from L&K BIOMED Co., Ltd.

510(k)DeviceDecision
K230482Swedge™ Pedicle Screw Fixation SystemNKB · Special 03/23/2023SE
K170045Swedge™ Pedicle Screw Fixation SystemNKB · Traditional 06/26/2017SE
K152662S-WireHTY · Traditional 03/09/2016SE

Questions and answers

When was Swedge™ Pedicle Screw Fixation System Bezier Rod cleared by the FDA?

Swedge™ Pedicle Screw Fixation System Bezier Rod (K252461) received a 510(k) decision of Substantially Equivalent on January 13, 2026, 161 days after the submission was received.

What is the product code of K252461?

The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.