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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K153222
Device Name Leva Spacer System
Applicant
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Applicant Contact Gail Yaeker-Daunis
Correspondent
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Correspondent Contact Amnon Talmor
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/06/2015
Decision Date 04/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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