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FDA 510(k)

Shoreline ACS (Anterior Cervical System)

K-Number: K201646 · 2020-09-14

ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-09-14
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shoreline ACS (Anterior Cervical System) is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-09-14 under approval number K201646. 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 Shoreline ACS (Anterior Cervical System)?

Shoreline ACS (Anterior Cervical System) is a medical device that received FDA 510(k) clearance on 2020-09-14. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K201646.

When was Shoreline ACS (Anterior Cervical System) approved by the FDA?

Shoreline ACS (Anterior Cervical System) received FDA 510(k) clearance on 2020-09-14, under approval number K201646.

What company makes Shoreline ACS (Anterior Cervical System)?

Shoreline ACS (Anterior Cervical System) is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Shoreline ACS (Anterior Cervical System)?

The FDA product code for Shoreline ACS (Anterior Cervical System) is OVE.

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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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