Name: Predicase
Price: 199 USD

K-number	K220452
Device name	Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
Applicant	Materialise NV
Product code	QHE
Device class	Class II
Decision date	Aug 17, 2022
Decision	Substantially Equivalent
Regulation	888.3660

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner

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