Name: Predicase
Price: 199 USD

K-number	K011810
Device name	ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
Applicant	Depuy, Inc.
Product code	KRO
Device class	Class II
Decision date	Sep 7, 2001
Decision	Substantially Equivalent
Regulation	888.3510

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 →

ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING

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