Name: Predicase
Price: 199 USD

K-number	K222383
Device name	Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition
Applicant	Medtronic Sofamor Danek USA, Inc.
Product code	OLO
Device class	Class II
Decision date	Sep 29, 2022
Decision	Substantially Equivalent
Regulation	882.4560

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 →

Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition

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

Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition