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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 K072785
Device Name TWINFIX FT PK
Applicant
Smith & Nephew Inc., Endoscopy Division
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact DEANA BOUSHELL
Correspondent
Smith & Nephew Inc., Endoscopy Division
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact DEANA BOUSHELL
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
JDR   MBI  
Date Received10/01/2007
Decision Date 12/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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