Name: Predicase
Price: 199 USD

K-number	K241143
Device name	Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Applicant	Materialise NV
Product code	QHE
Device class	Class II
Decision date	May 22, 2024
Decision	Substantially Equivalent
Regulation	888.3660

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

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

Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner