Product code NDL— Orthopedic
K'FIX
- Classification name
- Pin, Fixation, Smooth, Metallic
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code NDL
FDA has cleared devices under product code NDL, all in 2001, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code NDL
Recent clearances under product code NDL
Data sourced from openFDA. This site is unofficial and independent of the FDA.