The following data is part of a premarket notification filed by Spinevision, Inc. with the FDA for Uni-t Spinal System.
| Device ID | K013301 |
| 510k Number | K013301 |
| Device Name: | UNI-T SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINEVISION, INC. 3003 SUMMIT BLVD.; STE 1500 Atlanta, GA 30319 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker SPINEVISION, INC. 3003 SUMMIT BLVD.; STE 1500 Atlanta, GA 30319 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-03 |
| Decision Date | 2002-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03663136006222 | K013301 | 000 |
| 03663136005584 | K013301 | 000 |