T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K112059
Device Name T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
Applicant
Stryker
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact valerie giambanco
Correspondent
Stryker
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact valerie giambanco
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 07/19/2011
Decision Date 08/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No