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FDA 510(k)

Fule Interbody Fusion Cage System

K-Number: K253151 · 2026-06-15

ApplicantBeijing Fule Science & Technology Development Co., Ltd.
Decision Date2026-06-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fule Interbody Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K253151. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fule Interbody Fusion Cage System?

Fule Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. The 510(k) number is K253151.

When did Fule Interbody Fusion Cage System receive FDA 510(k) clearance?

Fule Interbody Fusion Cage System received FDA 510(k) clearance on 2026-06-15, under 510(k) number K253151.

Who is the listed applicant for Fule Interbody Fusion Cage System?

The FDA 510(k) record lists Beijing Fule Science & Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fule Interbody Fusion Cage System?

The FDA product code for Fule Interbody Fusion Cage System is MAX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Beijing Fule Science & Technology Development Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253155Fule Metallic Lockable Intramedullary Nail SystemsK252730Fule Spinal Fixation System

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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