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FDA 510(k)

OneLIF™ Interbody Fusion System

K-Number: K251459 · 2025-06-12

ApplicantNovapproach Spine, LLC
Decision Date2025-06-12
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OneLIF™ Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Novapproach Spine, LLC. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K251459. 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 OneLIF™ Interbody Fusion System?

OneLIF™ Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Novapproach Spine, LLC. The 510(k) number is K251459.

When did OneLIF™ Interbody Fusion System receive FDA 510(k) clearance?

OneLIF™ Interbody Fusion System received FDA 510(k) clearance on 2025-06-12, under 510(k) number K251459.

Who is the listed applicant for OneLIF™ Interbody Fusion System?

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

What is the FDA product code for OneLIF™ Interbody Fusion System?

The FDA product code for OneLIF™ Interbody Fusion System is OVD.

Other records listing Novapproach 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.

K211769OneLIF Intervertebral Body Replacement System

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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