K-number	K961890
Device name	FOUNDATION 9MM FORGED CEMENTED STEM
Applicant	Encore Orthopedics, Inc.
Product code	JDI
Device class	Class II
Decision date	Jun 14, 1996
Decision	Substantially Equivalent
Regulation	888.3350

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 →

FOUNDATION 9MM FORGED CEMENTED STEM

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