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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K093776
Device Name INDUS ANTERIOR CERVICAL PLATE SYSTEM
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 Number888.3060
Classification Product Code
KWQ  
Date Received12/08/2009
Decision Date 03/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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