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FDA 510(k)

Stable-C Interbody System

K-Number: K231763 · 2023-08-21

ApplicantNexus Spine, LLC
Decision Date2023-08-21
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stable-C Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Nexus Spine, LLC. It received FDA 510(k) clearance on 2023-08-21 under 510(k) number K231763. 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 Stable-C Interbody System?

Stable-C Interbody System is a medical device that received FDA 510(k) clearance on 2023-08-21. The listed applicant is Nexus Spine, LLC. The 510(k) number is K231763.

When did Stable-C Interbody System receive FDA 510(k) clearance?

Stable-C Interbody System received FDA 510(k) clearance on 2023-08-21, under 510(k) number K231763.

Who is the listed applicant for Stable-C Interbody System?

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

What is the FDA product code for Stable-C Interbody System?

The FDA product code for Stable-C Interbody System is OVE.

Other records listing Nexus Spine, LLC 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.

K261279DeltaNEC Interbody SystemK253331PressON Spinal Fixation SystemK243934Stable-L Lumbar Interbody SystemK241467Stable-C Interbody SystemK233375Tranquil-L Interbody SystemK240416Tranquil-C Interbody System

View all 18 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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