Product code HXI— Orthopedic
BOWEN KNOT PASSER
- Classification name
- Passer, Wire, Orthopedic
- Device class
- Class 1
- Regulation
- 21 CFR 888.4540
- Advisory panel
- Orthopedic
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code HXI
FDA has cleared devices under product code HXI between 1986 and 2014, filed by 2 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
- 2014
- 1986
Top applicants under product code HXI
Recent clearances under product code HXI
Data sourced from openFDA. This site is unofficial and independent of the FDA.