Name: Predicase
Price: 199 USD

K-number	K201346
Device name	DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
Applicant	Synthes (USA) Products, LLC
Product code	HSB
Device class	Class II
Decision date	Sep 23, 2020
Decision	Substantially Equivalent
Regulation	888.3020

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 →

DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

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