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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 a medical device manufactured by Vgi, LLC. It received FDA 510(k) clearance on 2016-01-13 under approval 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. It is manufactured by Vgi, LLC. The 510(k) number is K151312.

When was VerteLP Interbody Fusion Device approved by the FDA?

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

What company makes VerteLP Interbody Fusion Device?

VerteLP Interbody Fusion Device is manufactured by Vgi, LLC.

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

The FDA product code for VerteLP Interbody Fusion Device 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: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) 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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