Name: Predicase
Price: 199 USD

K-number	K130108
Device name	DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS
Applicant	Xiamen Double Engine Medical Material Co., Ltd.
Product code	HRS
Device class	Class II
Decision date	Apr 19, 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 →

DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS

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