XTRAFIX EXTERNAL FIXATION SYSTEM


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K111155
Device Name XTRAFIX EXTERNAL FIXATION SYSTEM
Applicant
EXTRAORTHO INC
901 king st
suite 200
alexandria, 
VA 
22314

Applicant Contact marcos velez-duran
Correspondent
EXTRAORTHO INC
901 king st
suite 200
alexandria, 
VA 
22314

Correspodent Contact marcos velez-duran
Regulation Number 888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received 04/25/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No