ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM


Device Classification Name

pin, fixation, smooth

510(k) Number K081097
Device Name ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL 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 888.3040
Classification Product Code
HTY  
Date Received 04/17/2008
Decision Date 06/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No