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: K170569
• 510k Number: K170569
• 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: Gina Flores
• Correspondent: Gina Flores; 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: 2017-02-27
• Decision Date: 2017-06-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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