The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Navigation System.
| Device ID | K172517 |
| 510k Number | K172517 |
| Device Name: | SeaSpine Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2018-05-11 |
| Summary: | summary |