Name: Predicase
Price: 199 USD

K-number	K210044
Device name	Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
Applicant	Spinal Elements, Inc.
Product code	MAX
Device class	Class II
Decision date	Jun 30, 2021
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 →

Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System

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