Name: Predicase
Price: 199 USD

K-number	K202498
Device name	4CIS SARA Spine System, 4CIS VERTU Spine System
Applicant	Solco Biomedical Company India Private Limited
Product code	NKB
Device class	Class II
Decision date	Feb 18, 2021
Decision	Substantially Equivalent
Regulation	888.3070

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 →

4CIS SARA Spine System, 4CIS VERTU Spine System

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