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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Fixation, Spinal Intervertebral Body
510(k) Number K883784
Device Name TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
Applicant
Warsaw Orthopedic, Inc.
P.O. Box 1157
Warsaw,  IN  46580
Applicant Contact JAMES RITTER
Correspondent
Warsaw Orthopedic, Inc.
P.O. Box 1157
Warsaw,  IN  46580
Correspondent Contact JAMES RITTER
Regulation Number888.4540
Classification Product Code
LYQ  
Date Received09/06/1988
Decision Date 04/06/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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