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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 a medical device manufactured by Novapproach Spine, LLC. It received FDA 510(k) clearance on 2025-06-12 under approval 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. It is manufactured by Novapproach Spine, LLC. The 510(k) number is K251459.

When was OneLIF™ Interbody Fusion System approved by the FDA?

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

What company makes OneLIF™ Interbody Fusion System?

OneLIF™ Interbody Fusion System is manufactured by Novapproach Spine, LLC.

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease 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)

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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