The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Shoreline Acs (anterior Cervical System).
| Device ID | K201646 |
| 510k Number | K201646 |
| Device Name: | Shoreline ACS (Anterior Cervical System) |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Alicia Mcarthur |
| Correspondent | Jesse Albright SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-17 |
| Decision Date | 2020-09-14 |