The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Mariner Outrigger Revision System.
| Device ID | K183639 |
| 510k Number | K183639 |
| Device Name: | Mariner Outrigger Revision System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Gina Flores |
| Correspondent | Martin Yahiro, M.d. SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981184995 | K183639 | 000 |
| 10889981184988 | K183639 | 000 |
| 10889981256111 | K183639 | 000 |
| 10889981235468 | K183639 | 000 |
| 10889981277857 | K183639 | 000 |
| 10889981277840 | K183639 | 000 |
| 10889981300203 | K183639 | 000 |