Name: Predicase
Price: 199 USD

K-number	K960424
Device name	BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
Applicant	Endotec, Inc.
Product code	KWT
Device class	Class II
Decision date	Aug 26, 1996
Decision	Substantially Equivalent
Regulation	888.3650

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 →

BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD

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