Name: Predicase
Price: 199 USD

K-number	K103189
Device name	MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
Applicant	Medacta International S.A.
Product code	LZO
Device class	Class II
Decision date	Dec 20, 2010
Decision	Substantially Equivalent
Regulation	888.3353

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 →

MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK

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