ORTHOPEDIATRICS PLATING SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K073344
Device Name ORTHOPEDIATRICS PLATING SYSTEM
Applicant
ORTHOPEDIATRICS, LLC
210 north buffalo street
warsaw, 
IN 
46580

Applicant Contact gary barnett
Correspondent
ORTHOPEDIATRICS, LLC
210 north buffalo street
warsaw, 
IN 
46580

Correspodent Contact gary barnett
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 11/28/2007
Decision Date 02/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No