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FDA 510(k)

SeaSpine Shoreline ACS - Anterior Cervical Standalone System

K-Number: K161081 · 2016-09-14

ApplicantSeaSpine Orthopedics Corporation
Decision Date2016-09-14
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 2016-09-14 under approval number K161081. 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 2016-09-14. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K161081.

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 2016-09-14, under approval number K161081.

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

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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 K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc. K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody SystemSpinal Elements, 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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