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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 K173864
Device Name Peekplus® Interbody Fusion Device
Applicant
Vallum Corporation
61 Spit Brook Rd.
Nashua,  NH  03060
Applicant Contact Stephen Blinn
Correspondent
O'Connell Regulatory Consultants, Inc.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/20/2017
Decision Date 07/02/2018
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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