DeviceClearance

Product code LXI— General, Plastic Surgery

ACL DRILL GUIDE SYSTEM

Classification name
Guide, Drill, Ligament
Device class
Class 1
Regulation
21 CFR 878.4820
Advisory panel
General, Plastic Surgery
Total cleared
8
First cleared
Most recent

Market context for product code LXI

FDA has cleared 8 devices under product code LXI between 1985 and 1994, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code LXI

Recent clearances under product code LXI

Data sourced from openFDA. This site is unofficial and independent of the FDA.