TRAUMA INTERNAL FIXATION SYSTEMS


Device Classification Name

plate, fixation, bone

510(k) Number K111663
Device Name TRAUMA INTERNAL FIXATION SYSTEMS
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 888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HSB   HTN   HTY   HWC   JDW  
KTT   LXT  
Date Received 06/14/2011
Decision Date 03/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No