Product code NDK— Orthopedic
EXTERNAL FIXATOR SYSTEM
- Classification name
- System, External Fixator (With Metallic Invasive Components)
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code NDK
FDA has cleared devices under product code NDK between 2010 and 2014, filed by 3 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
- 2014
- 2012
- 2010
Top applicants under product code NDK
Recent clearances under product code NDK
Data sourced from openFDA. This site is unofficial and independent of the FDA.