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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 the device name listed in this FDA 510(k) record. The listed applicant is Nexus Spine, LLC. It received FDA 510(k) clearance on 2022-03-18 under 510(k) 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. The listed applicant is Nexus Spine, LLC. The 510(k) number is K212498.

When did Stable-L Standalone Lumbar Interbody System receive FDA 510(k) clearance?

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

Who is the listed applicant for Stable-L Standalone Lumbar 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-L Standalone Lumbar Interbody System?

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

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

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Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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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