510(k) K140649
K140649 is an FDA 510(k) premarket notification submitted by 3D Medical Concepts, LLC for the device "VECTRIX EXTERNAL FIXATOR". The FDA issued a decision of Substantially Equivalent on December 29, 2014. The device falls under product code NDK (System, External Fixator (With Metallic Invasive Components)), a Class II device regulated under 21 CFR 888.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2014
- Date Received
- March 13, 2014
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, External Fixator (With Metallic Invasive Components)
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type