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FDA 510(k)

Fule Spinal Fixation System

K-Number: K252730 · 2025-10-24

ApplicantBeijing Fule Science & Technology Development Co., Ltd.
Decision Date2025-10-24
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fule Spinal Fixation System is a medical device manufactured by Beijing Fule Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2025-10-24 under approval number K252730. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fule Spinal Fixation System?

Fule Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Beijing Fule Science & Technology Development Co., Ltd.. The 510(k) number is K252730.

When was Fule Spinal Fixation System approved by the FDA?

Fule Spinal Fixation System received FDA 510(k) clearance on 2025-10-24, under approval number K252730.

What company makes Fule Spinal Fixation System?

Fule Spinal Fixation System is manufactured by Beijing Fule Science & Technology Development Co., Ltd..

What is the FDA product code for Fule Spinal Fixation System?

The FDA product code for Fule Spinal Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Related Devices (Code: NKB)

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Official Source

View on FDA Database →

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

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