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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 K132594
Device Name CROSSCHECK PLATING SYSTEM
Applicant
Solana Surgical, LLC
6363 Poplar Ave.
Suite 312
Memphis,  TN  38119
Applicant Contact JOE CLIFT
Correspondent
Solana Surgical, LLC
6363 Poplar Ave.
Suite 312
Memphis,  TN  38119
Correspondent Contact JOE CLIFT
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/19/2013
Decision Date 12/13/2013
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
Recalls CDRH Recalls
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