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FDA 510(k)

Genesys Spine AIS-C Cervical Stand-Alone System

K-Number: K181295 · 2018-08-29

ApplicantGenesys Spine
Decision Date2018-08-29
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine AIS-C Cervical Stand-Alone 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 2018-08-29 under 510(k) number K181295. 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 AIS-C Cervical Stand-Alone System?

Genesys Spine AIS-C Cervical Stand-Alone System is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Genesys Spine. The 510(k) number is K181295.

When did Genesys Spine AIS-C Cervical Stand-Alone System receive FDA 510(k) clearance?

Genesys Spine AIS-C Cervical Stand-Alone System received FDA 510(k) clearance on 2018-08-29, under 510(k) number K181295.

Who is the listed applicant for Genesys Spine AIS-C Cervical Stand-Alone 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 AIS-C Cervical Stand-Alone System?

The FDA product code for Genesys Spine AIS-C Cervical Stand-Alone 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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITINGNCT07259811Vertebral Augmentation Using VCFix Spinal System in Stand-alone ConfigurationACTIVE_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 SystemK191489Genesys Spine 3DP Cervical 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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