OLECRA INTRAMEDULLARY FIXATION SYSTEM


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K110322
Device Name OLECRA INTRAMEDULLARY FIXATION SYSTEM
Applicant
MYLAD ORTHOPEDIC SOLUTIONS
8803 windy creek way
mclean, 
VA 
22102

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

Correspodent Contact scott g edwards
Regulation Number 888.3020
Classification Product Code
HSB  
Subsequent Product Code
NDE  
Date Received 02/03/2011
Decision Date 03/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No