ORTHOPEDIATRICS PEDIPLATES SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K081407
Device Name ORTHOPEDIATRICS PEDIPLATES SYSTEM
Applicant
ORTHOPEDIATRICS, CORP.
210 n. buffalo st.
warsaw, 
IN 
46580

Applicant Contact gary barnett
Correspondent
ORTHOPEDIATRICS, CORP.
210 n. buffalo st.
warsaw, 
IN 
46580

Correspodent Contact gary barnett
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   OBT  
Date Received 05/19/2008
Decision Date 07/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No