K-number	K973854
Device name	ORION ANTERIOR CERVICAL PLATE SYSTEM
Applicant	Sofamor Danek USA,Inc.
Product code	KWQ
Device class	Class II
Decision date	Mar 16, 1998
Decision	Substantially Equivalent for Some Indications
Regulation	888.3060

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 →

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 →

ORION ANTERIOR CERVICAL PLATE SYSTEM

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