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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 integrated fixation, cervical
510(k) Number K120819
Device Name STALIF C
Applicant
CENTINEL SPINE, INC.
900 AIRPORT RD, STE #3B
WEST CHESTER,  PA  19380
Applicant Contact JOHN PARRY
Correspondent
CENTINEL SPINE, INC.
900 AIRPORT RD, STE #3B
WEST CHESTER,  PA  19380
Correspondent Contact JOHN PARRY
Regulation Number888.3080
Classification Product Code
OVE  
Date Received03/19/2012
Decision Date 08/31/2012
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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