Back to free search
Home / Search / K121102

OSTEOSYMBIONICS PEEK CRANIAL IMPLANT

Osteosymbionics, LLC · Class II · Cleared Aug 8, 2012

K-numberK121102
Device nameOSTEOSYMBIONICS PEEK CRANIAL IMPLANT
ApplicantOsteosymbionics, LLC
Product codeGXN
Device classClass II
Decision dateAug 8, 2012
DecisionSubstantially Equivalent
Regulation882.5330
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 →