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FDA 510(k)

Stable-C Interbody System

K-Number: K241467 · 2024-07-17

ApplicantNexus Spine, LLC
Decision Date2024-07-17
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stable-C Interbody System is a medical device manufactured by Nexus Spine, LLC. It received FDA 510(k) clearance on 2024-07-17 under approval number K241467. 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 2024-07-17. It is manufactured by Nexus Spine, LLC. The 510(k) number is K241467.

When was Stable-C Interbody System approved by the FDA?

Stable-C Interbody System received FDA 510(k) clearance on 2024-07-17, under approval number K241467.

What company makes Stable-C Interbody System?

Stable-C Interbody System is manufactured by Nexus Spine, LLC.

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07596394 A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy). RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT03418402 Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System COMPLETED NCT05006339 The Use of Remote Monitoring for Orthodontic Retention Review ACTIVE_NOT_RECRUITING NCT06939374 Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study RECRUITING

Other Devices by Nexus Spine, LLC

K160820PressON Pro Spinal Fixation System K170297Tranquil Interbody System K181621Stable-C Interbody System K181702Tranquil-L Interbody System K181483Tranquil Interbody System K212498Stable-L Standalone Lumbar Interbody System

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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.

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