OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K081356
Device Name OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
Applicant
MYLAD ORTHOPEDIC SOLUTIONS, LLC
8803 windy creek way
mclean, 
VA 
22102

Applicant Contact scott edwards
Correspondent
MYLAD ORTHOPEDIC SOLUTIONS, LLC
8803 windy creek way
mclean, 
VA 
22102

Correspodent Contact scott edwards
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 05/14/2008
Decision Date 07/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No