The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Mariner Pedicle Screw System.
| Device ID | K160902 |
| 510k Number | K160902 |
| Device Name: | Mariner Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SEASPINE ORTHOPEDICS CORPORATION 5770 ARMADA DRIVE Carlsbad, CA 92008 |
| Contact | Gina Flores |
| Correspondent | Gina Flores SEASPINE ORTHOPEDICS CORPORATION 5770 ARMADA DRIVE Carlsbad, CA 92008 |
| Product Code | NKB |
| Subsequent Product Code | KWQ |
| 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 | 2016-04-01 |
| Decision Date | 2016-05-26 |
| Summary: | summary |