Name: Predicase
Price: 199 USD

K-number	K210252
Device name	iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
Applicant	Conformis, Inc.
Product code	JWH
Device class	Class II
Decision date	Feb 17, 2021
Decision	Substantially Equivalent
Regulation	888.3560

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 →

iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System

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