Product code KWN— Orthopedic
AMC R METACARPAL COMPONENT
- Classification name
- Prosthesis, Wrist, Carpal Lunate
- Device class
- Class 2
- Regulation
- 21 CFR 888.3750
- Advisory panel
- Orthopedic
- Total cleared
- 5
- First cleared
- Most recent
Market context for product code KWN
FDA has cleared devices under product code KWN between 1979 and 2014, filed by 5 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
- 2008
- 2005
- 1987
- 1979
Top applicants under product code KWN
Recent clearances under product code KWN
Data sourced from openFDA. This site is unofficial and independent of the FDA.