Product code KWK— Orthopedic
CANNULATED MALLEOLAR SCREW
- Classification name
- Appliance, Nail/Blade/Plate Combination, Single Component
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code KWK
FDA has cleared device under product code KWK, all in 1994, filed by 1 applicant company. 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 KWK
Recent clearances under product code KWK
Data sourced from openFDA. This site is unofficial and independent of the FDA.