Product code HXR— General, Plastic Surgery

H-H HUNTER PASSIVE TENDON IMPLANT

Classification name
Spatula, Orthopedic
Device class
Class 1
Regulation
21 CFR 878.4800
Advisory panel
General, Plastic Surgery
Total cleared
4
First cleared
Most recent

Market context for product code HXR

FDA has cleared 4 devices under product code HXR between 1985 and 1999, filed by 4 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 HXR

Recent clearances under product code HXR

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