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FDA 510(k)

Stable-L Standalone Lumbar Interbody System

K-Number: K212498 · 2022-03-18

ApplicantNexus Spine, LLC
Decision Date2022-03-18
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stable-L Standalone Lumbar Interbody System is a medical device manufactured by Nexus Spine, LLC. It received FDA 510(k) clearance on 2022-03-18 under approval number K212498. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stable-L Standalone Lumbar Interbody System?

Stable-L Standalone Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2022-03-18. It is manufactured by Nexus Spine, LLC. The 510(k) number is K212498.

When was Stable-L Standalone Lumbar Interbody System approved by the FDA?

Stable-L Standalone Lumbar Interbody System received FDA 510(k) clearance on 2022-03-18, under approval number K212498.

What company makes Stable-L Standalone Lumbar Interbody System?

Stable-L Standalone Lumbar Interbody System is manufactured by Nexus Spine, LLC.

What is the FDA product code for Stable-L Standalone Lumbar Interbody System?

The FDA product code for Stable-L Standalone Lumbar Interbody System is OVD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_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 NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_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)

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 K233234PressON Spinal Fixation System

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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