TALON DISTALFIX PROXIMAL FEMORAL NAIL


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

Correspodent Contact seth masek
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 05/13/2011
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