The following data is part of a premarket notification filed by Baxano Surgical, Inc. with the FDA for Baxano Surgical Mis Spinal System.
| Device ID | K133743 |
| 510k Number | K133743 |
| Device Name: | BAXANO SURGICAL MIS SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | BAXANO SURGICAL, INC. 301 Government Center Drive Wilmington, NC 28403 |
| Contact | Kristen Allen |
| Correspondent | Kristen Allen BAXANO SURGICAL, INC. 301 Government Center Drive Wilmington, NC 28403 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-04-07 |
| Summary: | summary |