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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 K063584
Device Name STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937
Applicant
Regeneration Technologies, Inc.
11621 Research Cir.
P.O. Box 2650
Alachua,  FL  32616
Applicant Contact Lisa Simpson
Correspondent
Regeneration Technologies, Inc.
11621 Research Cir.
P.O. Box 2650
Alachua,  FL  32616
Correspondent Contact Lisa Simpson
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
JDR  
Date Received12/01/2006
Decision Date 05/09/2007
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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