K-number	K895607
Device name	POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
Applicant	Exactech, Inc.
Product code	JDL
Device class	Class III
Decision date	Nov 17, 1989
Decision	Substantially Equivalent for Some Indications
Regulation	888.3320

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 →

POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT

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