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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 Interlaminal
510(k) Number K880214
Device Name TSRH H/M TORQUE LIMITING WRENCH
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 Number888.3050
Classification Product Code
KWP  
Date Received01/19/1988
Decision Date 02/18/1988
Decision Substantially Equivalent (SESE)
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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