The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Mariner Pedicle Screw System.
| Device ID | K212692 |
| 510k Number | K212692 |
| Device Name: | Mariner Pedicle Screw 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-25 |
| Decision Date | 2021-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981283803 | K212692 | 000 |