Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CorticaLINK Spinal Fusion Platform

K-Number: K160722 · 2016-07-07

ApplicantFacetlink Dba Linkspine
Decision Date2016-07-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CorticaLINK Spinal Fusion Platform is a medical device manufactured by Facetlink Dba Linkspine. It received FDA 510(k) clearance on 2016-07-07 under approval number K160722. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorticaLINK Spinal Fusion Platform?

CorticaLINK Spinal Fusion Platform is a medical device that received FDA 510(k) clearance on 2016-07-07. It is manufactured by Facetlink Dba Linkspine. The 510(k) number is K160722.

When was CorticaLINK Spinal Fusion Platform approved by the FDA?

CorticaLINK Spinal Fusion Platform received FDA 510(k) clearance on 2016-07-07, under approval number K160722.

What company makes CorticaLINK Spinal Fusion Platform?

CorticaLINK Spinal Fusion Platform is manufactured by Facetlink Dba Linkspine.

What is the FDA product code for CorticaLINK Spinal Fusion Platform?

The FDA product code for CorticaLINK Spinal Fusion Platform is NKB.

Related Clinical Trials

NCT07615491 PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials RECRUITING NCT07603609 Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain RECRUITING NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT07578454 VRehab-SMA Phase 1.2 NOT_YET_RECRUITING NCT06647576 Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs COMPLETED NCT07507422 Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Facetlink Dba Linkspine

K162693VertebraLINK Fusion Platform

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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.

↑