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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 K261159
Device Name Exceed® Biplanar Expandable Interbody System
Applicant
Spine Wave, Inc.
Three Enterprise Dr.
Suite 210
Shelton,  CT  06484
Applicant Contact Ronald Smith
Correspondent
Spine Wave, Inc.
Three Enterprise Dr.
Suite 210
Shelton,  CT  06484
Correspondent Contact Ronald Smith
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/08/2026
Decision Date 05/29/2026
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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