Spinal Inner Fixation System

FDA 510(k) K222031 · Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

Substantially Equivalent

510(k) numberK222031

Submission

Device name
Spinal Inner Fixation System
Applicant
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Changzhou, CN
Received
July 11, 2022
Decision date
October 28, 2022
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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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
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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
K232394Internal Locking Plate and Screw Fixation SystemHRS · Traditional 12/15/2023SE
K230456SGM Femoral Nail SystemHSB · Traditional 06/30/2023SE
K223776PEEK Spinal Infusion CageMAX · Traditional 03/03/2023SE

Questions and answers

When was Spinal Inner Fixation System cleared by the FDA?

Spinal Inner Fixation System (K222031) received a 510(k) decision of Substantially Equivalent on October 28, 2022, 109 days after the submission was received.

What is the product code of K222031?

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