Name: Predicase
Price: 199 USD

K-number	K193320
Device name	KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
Applicant	Kyocera Medical Technologies, Inc.
Product code	OVD
Device class	Class II
Decision date	Feb 4, 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 →

KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System

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