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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, Intraosseous
510(k) Number K964261
Device Name SMF STAINLESS STEEL BONE SCREWS
Applicant
Synthes (Usa)
1690 Russell Rd.
P.O. Box 1766
Paoli,  PA  19301
Applicant Contact ANGELA J SILVESTRI
Correspondent
Synthes (Usa)
1690 Russell Rd.
P.O. Box 1766
Paoli,  PA  19301
Correspondent Contact ANGELA J SILVESTRI
Regulation Number872.4880
Classification Product Code
DZL  
Date Received10/25/1996
Decision Date 04/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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