DeviceClearance

Product code HSR— Orthopedic

ENTRAX TRACTION UNIT

Classification name
Unit, Traction, Hip, Non-Powered, Non-Penetrating
Device class
Class 1
Regulation
21 CFR 888.5890
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

Market context for product code HSR

FDA has cleared 1 device under product code HSR, all in 1978, filed by 1 applicant company. 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.

Top applicants under product code HSR

Recent clearances under product code HSR

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