The following data is part of a premarket notification filed by 3d Medical Concepts, Llc with the FDA for Vectrix External Fixator.
| Device ID | K140649 |
| 510k Number | K140649 |
| Device Name: | VECTRIX EXTERNAL FIXATOR |
| Classification | System, External Fixator (with Metallic Invasive Components) |
| Applicant | 3D MEDICAL CONCEPTS, LLC 1061 MORGAN PARK RD. Pelham, AL 35242 |
| Contact | Beverly Laird |
| Correspondent | Beverly Laird 3D MEDICAL CONCEPTS, LLC 1061 MORGAN PARK RD. Pelham, AL 35242 |
| Product Code | NDK |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-13 |
| Decision Date | 2014-12-29 |
| Summary: | summary |