Product code NDF— Orthopedic
EBI DYNAFIX VS OSTEOTOMY SYSTEM
- Classification name
- Plate, Fixation, Bone, Non-Spinal, Metallic
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code NDF
FDA has cleared devices under product code NDF between 2001 and 2005, 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.
Clearances per year
- 2005
- 2002
- 2001
Top applicants under product code NDF
Recent clearances under product code NDF
Data sourced from openFDA. This site is unofficial and independent of the FDA.