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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 K122738
Device Name GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
Applicant
Solana Surgical, LLC
6363 Poplar Ave.
Suite 434
Memphis,  TN  38119
Applicant Contact REBECCA WAHL
Correspondent
Solana Surgical, LLC
6363 Poplar Ave.
Suite 434
Memphis,  TN  38119
Correspondent Contact REBECCA WAHL
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/06/2012
Decision Date 11/07/2012
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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