Fule Interbody Fusion Cage System

Q: What is the product code of K253151?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K253151 · Beijing Fule Science & Technology Development Co., Ltd.

Substantially Equivalent

510(k) numberK253151

Submission

Device name: Fule Interbody Fusion Cage System
Applicant: Beijing Fule Science & Technology Development Co., Ltd.
Beijing, CN
Received: September 26, 2025
Decision date: June 15, 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: MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other 510(k)s with product code MAX

510(k)	Device	Applicant	Decision
K261049	Scala® TLMAX · Traditional	Spineart SA	08/20/2026SE
K261430	TruLift Expandable SystemMAX · Traditional	Life Spine, Inc.	07/28/2026SE
K253011	Catalyft PL Expandable Interbody SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/17/2026SE
K261020	Symmetrix L Spinal SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/14/2026SE
K253420	Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional	SeaSpine Orthopedics Corporation	07/01/2026SE
K261159	Exceed® Biplanar Expandable Interbody SystemMAX · Traditional	Spine Wave, Inc.	05/29/2026SE
K253894	BMD Titanium Spinal Fusion SystemMAX · Traditional	Global Biomedica s.r.o.	05/28/2026SE
K260506	Ventana® P/T Lumbar Interbody SystemMAX · Traditional	Spinal Elements, Inc.	05/15/2026SE
K260837	VersaLift Expandable SystemMAX · Traditional	Life Spine, Inc.	05/12/2026SE
K260385	aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…MAX · Traditional	Carlsmed, Inc.	05/09/2026SE

More from Carlsmed, Inc.

510(k)	Device	Decision
K260203	Fule Vertebroplasty Balloon CatheterHRX · Traditional	08/28/2026SE
K253155	Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional	06/17/2026SE
K252730	Fule Spinal Fixation SystemNKB · Traditional	10/24/2025SE

Questions and answers

When was Fule Interbody Fusion Cage System cleared by the FDA?

Fule Interbody Fusion Cage System (K253151) received a 510(k) decision of Substantially Equivalent on June 15, 2026, 262 days after the submission was received.

What is the product code of K253151?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.