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FDA 510(k)

Leva® Anterior Interbody System

K-Number: K161993 · 2016-11-22

ApplicantSpine Wave, Inc.
Decision Date2016-11-22
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Leva® Anterior Interbody System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2016-11-22 under approval number K161993. 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 Leva® Anterior Interbody System?

Leva® Anterior Interbody System is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Spine Wave, Inc.. The 510(k) number is K161993.

When was Leva® Anterior Interbody System approved by the FDA?

Leva® Anterior Interbody System received FDA 510(k) clearance on 2016-11-22, under approval number K161993.

What company makes Leva® Anterior Interbody System?

Leva® Anterior Interbody System is manufactured by Spine Wave, Inc..

What is the FDA product code for Leva® Anterior Interbody System?

The FDA product code for Leva® Anterior Interbody System is OVD.

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Other Devices by Spine Wave, Inc.

K153222Leva Spacer System K160003Sniper (R) Spine System K152620Spine Wave Gen II Expandable Interbody System K172594Proficient® Posterior Cervical Spine System K173175Paramount Anterior Cervical Cage System K172175CapSure® PS System

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc. K160597INDEPENDENCE MIS SpacersGlobus 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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