Name: Predicase
Price: 199 USD

K-number	K250520
Device name	OsteoCentric Navigated Instruments System
Applicant	Osteocentric Technologies, Inc.
Product code	OLO
Device class	Class II
Decision date	Oct 27, 2025
Decision	Substantially Equivalent
Regulation	882.4560

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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OsteoCentric Navigated Instruments System

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