Back to free search
Home / Search / K051642

FR.O.H. CALCANEUS REPAIR SYSTEM

I.T.S. Implantat-Technologie-Systeme GmbH · Class II · Cleared Aug 22, 2005

K-numberK051642
Device nameFR.O.H. CALCANEUS REPAIR SYSTEM
ApplicantI.T.S. Implantat-Technologie-Systeme GmbH
Product codeNDF
Device classClass II
Decision dateAug 22, 2005
DecisionSubstantially Equivalent
Regulation888.3030
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 →

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

14-day free trial. No setup. Cancel anytime.

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 →