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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K013890
Device Name SURGICAL DYNAMICS MENISCAL STAPLE
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact JENNIFER SCHUCK
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact JENNIFER SCHUCK
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/23/2001
Decision Date 12/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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