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FDA 510(k)

VerteLP Interbody Fusion Device

K-Number: K151312 · 2016-01-13

ApplicantVgi, LLC
Decision Date2016-01-13
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VerteLP Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Vgi, LLC. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K151312. 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 VerteLP Interbody Fusion Device?

VerteLP Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Vgi, LLC. The 510(k) number is K151312.

When did VerteLP Interbody Fusion Device receive FDA 510(k) clearance?

VerteLP Interbody Fusion Device received FDA 510(k) clearance on 2016-01-13, under 510(k) number K151312.

Who is the listed applicant for VerteLP Interbody Fusion Device?

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

What is the FDA product code for VerteLP Interbody Fusion Device?

The FDA product code for VerteLP Interbody Fusion Device is OVD.

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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