The following data is part of a premarket notification filed by Spine Vision, Inc with the FDA for Uni-thread Spinal System.
| Device ID | K052406 |
| 510k Number | K052406 |
| Device Name: | UNI-THREAD SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINE VISION, INC 3003 SUMMIT BLVD., SUITE 1400 Atlanta, GA 30319 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker SPINE VISION, INC 3003 SUMMIT BLVD., SUITE 1400 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 | 2005-09-01 |
| Decision Date | 2005-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03663136032658 | K052406 | 000 |
| 03663136032641 | K052406 | 000 |
| 03663136020044 | K052406 | 000 |
| 03663136020006 | K052406 | 000 |
| 03663136005867 | K052406 | 000 |