The following data is part of a premarket notification filed by Spine Vision, Inc with the FDA for Uni-t Uni-thread Spinal System.
| Device ID | K021510 |
| 510k Number | K021510 |
| Device Name: | UNI-T UNI-THREAD SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINE VISION, INC 3003 SUMMIT BLVD. 15TH FLOOR SUITE 1500 Atlanta, GA 30319 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker SPINE VISION, INC 3003 SUMMIT BLVD. 15TH FLOOR SUITE 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 | 2002-05-09 |
| Decision Date | 2002-08-01 |
| Summary: | summary |