Name: Predicase
Price: 199 USD

K-number	K053505
Device name	REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS
Applicant	Biomet Manufacturing, Inc.
Product code	MBH
Device class	Class II
Decision date	Aug 14, 2006
Decision	Substantially Equivalent
Regulation	888.3565

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 →

REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS

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