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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K124045
Device Name FUSEFORCE IMPLANT 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
JDR  
Date Received12/31/2012
Decision Date 07/10/2013
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
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