Name: Predicase
Price: 199 USD

K-number	K253377
Device name	Expandable Titanium PLIF/TLIF System
Applicant	Spectrum Spine, Inc.
Product code	MAX
Device class	Class II
Decision date	Oct 24, 2025
Decision	Substantially Equivalent
Regulation	888.3080

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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Expandable Titanium PLIF/TLIF System

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