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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 the device name listed in this FDA 510(k) record. The listed applicant is Novapproach Spine. It received FDA 510(k) clearance on 2021-09-07 under 510(k) 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. The listed applicant is Novapproach Spine. The 510(k) number is K211769.

When did OneLIF Intervertebral Body Replacement System receive FDA 510(k) clearance?

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

Who is the listed applicant for OneLIF Intervertebral Body Replacement System?

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

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

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

Other records listing Novapproach Spine 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.

K251459OneLIF™ Interbody Fusion 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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