Name: Predicase
Price: 199 USD

K-number	K854107
Device name	DIMENSION TOTAL HIP PROSTHESIS POROUS COATED
Applicant	Kirschner Medical Corp.
Product code	JDL
Device class	Class III
Decision date	Mar 10, 1986
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 →

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

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