Fule Spinal Fixation System

FDA 510(k) K252730 · Beijing Fule Science & Technology Development Co., Ltd.

Substantially Equivalent

510(k) numberK252730

Submission

Device name
Fule Spinal Fixation System
Applicant
Beijing Fule Science & Technology Development Co., Ltd.
Beijing, CN
Received
August 28, 2025
Decision date
October 24, 2025
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.

Other 510(k)s with product code NKB

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K262828KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special S.M.A.I.O09/04/2026SE
K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional MANTIZ Co., Ltd.07/24/2026SE
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
K260203Fule Vertebroplasty Balloon CatheterHRX · Traditional 08/28/2026SE
K253155Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional 06/17/2026SE
K253151Fule Interbody Fusion Cage SystemMAX · Traditional 06/15/2026SE

Questions and answers

When was Fule Spinal Fixation System cleared by the FDA?

Fule Spinal Fixation System (K252730) received a 510(k) decision of Substantially Equivalent on October 24, 2025, 57 days after the submission was received.

What is the product code of K252730?

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