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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K111352
Device Name TALON DISTALFIX PROXIMAL FEMORAL NAIL
Applicant
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
5912 BRECKENRIDGE PARKWAY
SUITE F
tampa,  FL  33610
Applicant Contact seth masek
Correspondent
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
5912 BRECKENRIDGE PARKWAY
SUITE F
tampa,  FL  33610
Correspondent Contact seth masek
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/13/2011
Decision Date 08/22/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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