System, External Fixator (With Metallic Invasive Components)

FDA product code NDK · Class II (moderate risk) · 21 CFR 888.3040 · Orthopedic

3510(k) clearances
0PMA approvals
0recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K140649Vectrix External FixatorNDK · Abbreviated 3D Medical Concepts, LLC12/29/2014SE
K122208External Fixator SystemNDK · Traditional Christopher D. Endara12/20/2012SE
K101375Trimed X-FixNDK · Traditional TriMed, Inc.09/15/2010SE