Name: Predicase
Price: 199 USD

K-number	K142648
Device name	SPINEDESIGN Spine Surgery Planning (Software Application)
Applicant	Medtronic Sofamor Danek USA, Inc.
Product code	LLZ
Device class	Class II
Decision date	May 22, 2015
Decision	Substantially Equivalent
Regulation	892.2050

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 →

SPINEDESIGN Spine Surgery Planning (Software Application)

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