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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K052538
Device Name S-BONE HIP TOOL
Applicant
Orthopedic Sciences, Inc.
3020 Old Ranch Pkwy.
Suite 325
Seal Beach,  CA  90740
Applicant Contact JAMES K BRANNON
Correspondent
Orthopedic Sciences, Inc.
3020 Old Ranch Pkwy.
Suite 325
Seal Beach,  CA  90740
Correspondent Contact JAMES K BRANNON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/15/2005
Decision Date 10/07/2005
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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