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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, fixation device, spinal
510(k) Number K760649
Device Name TOTAL SPINAL CORRECTION
Applicant
DEPUY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DEPUY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3060
Classification Product Code
JDN  
Date Received09/15/1976
Decision Date 10/05/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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