Back to free search
Home / Search / K011052

OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE

Ostex Intl., Inc. · Class I · Cleared Jul 30, 2001

K-numberK011052
Device nameOSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
ApplicantOstex Intl., Inc.
Product codeJMM
Device classClass I
Decision dateJul 30, 2001
DecisionSubstantially Equivalent
Regulation862.1400
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 →