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FDA 510(k)

SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System

K-Number: K190655 · 2019-04-29

ApplicantSeaSpine Orthopedics Corporation
Decision Date2019-04-29
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2019-04-29 under approval number K190655. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System?

SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System is a medical device that received FDA 510(k) clearance on 2019-04-29. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K190655.

When was SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System approved by the FDA?

SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System received FDA 510(k) clearance on 2019-04-29, under approval number K190655.

What company makes SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System?

SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System?

The FDA product code for SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System is OVE.

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Other Devices by SeaSpine Orthopedics Corporation

K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System K161535SeaSpine® NewPort™ Spinal System K160902Mariner Pedicle Screw System K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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