The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Mariner Rdx System.
| Device ID | K222110 |
| 510k Number | K222110 |
| Device Name: | Mariner RDX System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Jesse Albright |
| Correspondent | Jesse Albright SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-18 |
| Decision Date | 2022-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981298647 | K222110 | 000 |
| 10889981289874 | K222110 | 000 |
| 10889981319588 | K222110 | 000 |
| 10889981319571 | K222110 | 000 |