The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Mariner Cap System.
| Device ID | K201240 |
| 510k Number | K201240 |
| Device Name: | Mariner Cap System |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Alicia Mcarthur |
| Correspondent | Alicia Mcarthur SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-08 |
| Decision Date | 2020-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981239862 | K201240 | 000 |
| 10889981239855 | K201240 | 000 |
| 10889981220945 | K201240 | 000 |
| 10889981220938 | K201240 | 000 |
| 10889981220921 | K201240 | 000 |
| 10889981220914 | K201240 | 000 |
| 10889981220907 | K201240 | 000 |