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FDA 510(k)

Pro-Link® Ti Stand-Alone Cervical Spacer System

K-Number: K180642 · 2018-05-10

ApplicantLife Spine, Inc.
Decision Date2018-05-10
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pro-Link® Ti Stand-Alone Cervical Spacer System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2018-05-10 under approval number K180642. 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 Pro-Link® Ti Stand-Alone Cervical Spacer System?

Pro-Link® Ti Stand-Alone Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2018-05-10. It is manufactured by Life Spine, Inc.. The 510(k) number is K180642.

When was Pro-Link® Ti Stand-Alone Cervical Spacer System approved by the FDA?

Pro-Link® Ti Stand-Alone Cervical Spacer System received FDA 510(k) clearance on 2018-05-10, under approval number K180642.

What company makes Pro-Link® Ti Stand-Alone Cervical Spacer System?

Pro-Link® Ti Stand-Alone Cervical Spacer System is manufactured by Life Spine, Inc..

What is the FDA product code for Pro-Link® Ti Stand-Alone Cervical Spacer System?

The FDA product code for Pro-Link® Ti Stand-Alone Cervical Spacer System is OVE.

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Other Devices by Life Spine, Inc.

K161127The Small PLATEAU (PLATEAU-C) Spacer System K160066Pro-Link® Stand-Alone Cervical Spacer System K161037Tarsa-Link Stand-Alone Wedge Fixation System K153065The Hammertoe Correction System K153400ProLift Expandable System K172973Life Spine Foot and Ankle Plating System

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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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