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510(k) K161993

Leva® Anterior Interbody System by Spine Wave, Inc. — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 22, 2016
Date Received: July 19, 2016
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

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