The following data is part of a premarket notification filed by Spinevision, Inc. with the FDA for Uni-thread Spinal System.
| Device ID | K042640 |
| 510k Number | K042640 |
| Device Name: | UNI-THREAD SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SPINEVISION, INC. 3003 SUMMIT BLVD. STE 1400 Atlanta, GA 30319 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker SPINEVISION, INC. 3003 SUMMIT BLVD. STE 1400 Atlanta, GA 30319 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2004-11-23 |
| Summary: | summary |