K-number	K954627
Device name	ECTRA II LIGAMENT RELEASE SYSTEM
Applicant	Smith & Nephew Dyonics, Inc.
Product code	HRX
Device class	Class II
Decision date	Dec 18, 1995
Decision	Substantially Equivalent for Some Indications
Regulation	888.1100

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 →

ECTRA II LIGAMENT RELEASE SYSTEM

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