The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Solanas Posterior Stabilization System.
| Device ID | K131119 |
| 510k Number | K131119 |
| Device Name: | SOLANAS POSTERIOR STABILIZATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Contact | Trevor Denbo |
| Correspondent | Trevor Denbo ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-22 |
| Decision Date | 2013-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844856064249 | K131119 | 000 |
| 00844856064232 | K131119 | 000 |