ORTHOPEDIATRICS BLADE PLATE SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K110959
Device Name ORTHOPEDIATRICS BLADE PLATE SYSTEM
Applicant
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, 
IN 
46582

Applicant Contact mark fox
Correspondent
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, 
IN 
46582

Correspodent Contact mark fox
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 04/05/2011
Decision Date 08/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls