Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OneLIF Intervertebral Body Replacement System

K-Number: K211769 · 2021-09-07

ApplicantNovapproach Spine
Decision Date2021-09-07
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OneLIF Intervertebral Body Replacement System is a medical device manufactured by Novapproach Spine. It received FDA 510(k) clearance on 2021-09-07 under approval number K211769. 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 Intervertebral Body Replacement System?

OneLIF Intervertebral Body Replacement System is a medical device that received FDA 510(k) clearance on 2021-09-07. It is manufactured by Novapproach Spine. The 510(k) number is K211769.

When was OneLIF Intervertebral Body Replacement System approved by the FDA?

OneLIF Intervertebral Body Replacement System received FDA 510(k) clearance on 2021-09-07, under approval number K211769.

What company makes OneLIF Intervertebral Body Replacement System?

OneLIF Intervertebral Body Replacement System is manufactured by Novapproach Spine.

What is the FDA product code for OneLIF Intervertebral Body Replacement System?

The FDA product code for OneLIF Intervertebral Body Replacement System is OVD.

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT06608823 ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING

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.

↑