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FDA 510(k)

CorticaLINK Spinal Fusion Platform

K-Number: K193465 · 2020-01-10

ApplicantSpine Smith Holdings, LLC
Decision Date2020-01-10
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CorticaLINK Spinal Fusion Platform is a medical device manufactured by Spine Smith Holdings, LLC. It received FDA 510(k) clearance on 2020-01-10 under approval number K193465. 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 2020-01-10. It is manufactured by Spine Smith Holdings, LLC. The 510(k) number is K193465.

When was CorticaLINK Spinal Fusion Platform approved by the FDA?

CorticaLINK Spinal Fusion Platform received FDA 510(k) clearance on 2020-01-10, under approval number K193465.

What company makes CorticaLINK Spinal Fusion Platform?

CorticaLINK Spinal Fusion Platform is manufactured by Spine Smith Holdings, LLC.

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)

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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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