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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 K112923
Device Name SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
Applicant
Suspension Orthopaedic Solutions, LLC
80 Shelton Technology Center
Shelton,  CT  06484
Applicant Contact CURTIS RAYMOND
Correspondent
Suspension Orthopaedic Solutions, LLC
80 Shelton Technology Center
Shelton,  CT  06484
Correspondent Contact CURTIS RAYMOND
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   MBI  
Date Received10/03/2011
Decision Date 12/27/2011
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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