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FDA 510(k)

Leva Anterior Expandable Spacer System

K-Number: K163246 · 2017-04-06

ApplicantSpine Wave, Inc.
Decision Date2017-04-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Leva Anterior Expandable Spacer System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2017-04-06 under approval number K163246. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Leva Anterior Expandable Spacer System?

Leva Anterior Expandable Spacer System is a medical device that received FDA 510(k) clearance on 2017-04-06. It is manufactured by Spine Wave, Inc.. The 510(k) number is K163246.

When was Leva Anterior Expandable Spacer System approved by the FDA?

Leva Anterior Expandable Spacer System received FDA 510(k) clearance on 2017-04-06, under approval number K163246.

What company makes Leva Anterior Expandable Spacer System?

Leva Anterior Expandable Spacer System is manufactured by Spine Wave, Inc..

What is the FDA product code for Leva Anterior Expandable Spacer System?

The FDA product code for Leva Anterior Expandable Spacer System is MAX.

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Other Devices by Spine Wave, Inc.

K161993Leva® Anterior Interbody System K153222Leva Spacer System K160003Sniper (R) Spine System K152620Spine Wave Gen II Expandable Interbody System K172594Proficient® Posterior Cervical Spine System K173175Paramount Anterior Cervical Cage System

View all 22 devices →

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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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