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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 K120293
Device Name SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
Applicant
SPINEOLOGY, INC.
7800 3RD ST N., SUITE 600
ST. PAUL,  MN  55128
Applicant Contact BRYAN BECKER
Correspondent
SPINEOLOGY, INC.
7800 3RD ST N., SUITE 600
ST. PAUL,  MN  55128
Correspondent Contact BRYAN BECKER
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/31/2012
Decision Date 02/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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