SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System
Intervertebral Fusion Device With Integrated Fixation, Cervical
SeaSpine Orthopedics Corporation
The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine® Shoreline™ Acs- Anterior Cervical Standalone System.
Pre-market Notification Details
| Device ID | K190655 |
| 510k Number | K190655 |
| Device Name: | SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| 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 | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-14 |
| Decision Date | 2019-04-29 |
Trademark Results [SeaSpine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEASPINE 86655624 4970455 Live/Registered |
SeaSpine, Inc. 2015-06-08 |
 SEASPINE 86459554 4919176 Live/Registered |
SeaSpine, Inc. 2014-11-20 |
 SEASPINE 76418251 2688666 Live/Registered |
SeaSpine, Inc. 2002-06-10 |
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