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FDA 510(k)

Genesys Spine 3DP Cervical Interbody System

K-Number: K191489 · 2020-01-08

ApplicantGenesys Spine
Decision Date2020-01-08
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine 3DP Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2020-01-08 under 510(k) number K191489. 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 Genesys Spine 3DP Cervical Interbody System?

Genesys Spine 3DP Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2020-01-08. The listed applicant is Genesys Spine. The 510(k) number is K191489.

When did Genesys Spine 3DP Cervical Interbody System receive FDA 510(k) clearance?

Genesys Spine 3DP Cervical Interbody System received FDA 510(k) clearance on 2020-01-08, under 510(k) number K191489.

Who is the listed applicant for Genesys Spine 3DP Cervical Interbody System?

The FDA 510(k) record lists Genesys Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Genesys Spine 3DP Cervical Interbody System?

The FDA product code for Genesys Spine 3DP Cervical Interbody System is OVE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITING

Other records listing Genesys Spine as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252322SIros-X SystemK242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemK233595Genesys Spine Sacroiliac Joint Fusion System with NavigationK233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemK220096Genesys Spine 3DP Lumbar Interbody SystemK182987Genesys Spine 3DP Lumbar Interbody System

View all 21 devices →

Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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