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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 K060253
Device Name STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
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  
Date Received02/01/2006
Decision Date 02/23/2006
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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