UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K111444
Device Name UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Applicant Contact suzana otano
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Correspodent Contact suzana otano
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 05/24/2011
Decision Date 06/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No