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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K002605
Device Name 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
Applicant
Synthes (Usa)
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact BONNIE J SMITH
Correspondent
Synthes (Usa)
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact BONNIE J SMITH
Regulation Number888.3040
Classification Product Code
JDW  
Date Received08/22/2000
Decision Date 11/20/2000
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
Recalls CDRH Recalls
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