The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Arsenal Spinal Fixation System.
| Device ID | K143149 |
| 510k Number | K143149 |
| Device Name: | Arsenal Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Contact | Renee Murphy |
| Correspondent | Renee Murphy ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-01-05 |
| Summary: | summary |