Product code HXN— Orthopedic
OSTEO-CABLE SLEEVE
- Classification name
- Applier, Cerclage
- Device class
- Class 1
- Regulation
- 21 CFR 888.4540
- Advisory panel
- Orthopedic
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code HXN
FDA has cleared devices under product code HXN between 1984 and 2003, 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
- 2003
- 1984
Top applicants under product code HXN
Recent clearances under product code HXN
Data sourced from openFDA. This site is unofficial and independent of the FDA.