K-number	K110836
Device name	CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
Applicant	Zimmer GmbH
Product code	KWA
Device class	Class III
Decision date	Oct 7, 2011
Decision	Substantially Equivalent
Regulation	888.3330

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY

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