The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Mariner Pedicle Screw System.
| Device ID | K173882 | 
| 510k Number | K173882 | 
| Device Name: | SeaSpine 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 | 
| CFR Regulation Number | 888.3070 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2017-12-21 | 
| Decision Date | 2018-02-06 | 
| Summary: | summary |