Name: Predicase
Price: 199 USD

K-number	K191581
Device name	Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
Applicant	Titan Spine, Inc.
Product code	OVD
Device class	Class II
Decision date	Jan 8, 2020
Decision	Substantially Equivalent
Regulation	888.3080

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 →

Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device

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