Name: Predicase
Price: 199 USD

K-number	K123347
Device name	NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
Applicant	Normed Medizin-Technik GmbH
Product code	HRS
Device class	Class II
Decision date	Aug 2, 2013
Decision	Substantially Equivalent
Regulation	888.3030

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 →

NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0

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