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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 K092815
Device Name S-LIF INTERVERTEBRAL BODY FUSION DEVICE
Applicant
SPINEFRONTIER, INC.
500 CUMMINGS CENTER, STE. 3500
BEVERLY,  MA  01915
Applicant Contact JOHN SULLIVAN
Correspondent
SPINEFRONTIER, INC.
500 CUMMINGS CENTER, STE. 3500
BEVERLY,  MA  01915
Correspondent Contact JOHN SULLIVAN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/14/2009
Decision Date 06/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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