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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 K111880
Device Name SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
Applicant
Spineology, Inc.
7800 Third St. N., Suite 600
St. Paul,  MN  55128
Applicant Contact BRYAN BECKER
Correspondent
Spineology, Inc.
7800 Third St. N., Suite 600
St. Paul,  MN  55128
Correspondent Contact BRYAN BECKER
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/01/2011
Decision Date 09/26/2011
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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