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 |