Name: Predicase
Price: 199 USD

K-number	K022890
Device name	MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
Applicant	Bioplate, Inc.
Product code	JEY
Device class	Class II
Decision date	Sep 6, 2002
Decision	Substantially Equivalent
Regulation	872.4760

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 →

MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

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