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FDA 510(k)

Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System

K-Number: K231704 · 2023-10-19

ApplicantLife Spine, Inc.
Decision Date2023-10-19
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2023-10-19 under approval number K231704. 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® & Pro-Link® Ti Barbs Cervical Spacer System?

Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2023-10-19. It is manufactured by Life Spine, Inc.. The 510(k) number is K231704.

When was Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System approved by the FDA?

Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System received FDA 510(k) clearance on 2023-10-19, under approval number K231704.

What company makes Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System?

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

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

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

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING

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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