Name: Predicase
Price: 199 USD

K-number	K252730
Device name	Fule Spinal Fixation System
Applicant	Beijing Fule Science & Technology Development Co., Ltd.
Product code	NKB
Device class	Class II
Decision date	Oct 24, 2025
Decision	Substantially Equivalent
Regulation	888.3070

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Fule Spinal Fixation System

Everything you need for a 510(k) submission. Nothing you don't.