ARTHREX FRACTURE SYSTEM


Device Classification Name

washer, bolt nut

510(k) Number K112437
Device Name ARTHREX FRACTURE SYSTEM
Applicant
ARTHREX, INC.
1370 creekside blvd.
naples, 
FL 
34108 -1945

Applicant Contact courtney smith
Correspondent
ARTHREX, INC.
1370 creekside blvd.
naples, 
FL 
34108 -1945

Correspodent Contact courtney smith
Regulation Number 888.3030
Classification Product Code
HTN  
Subsequent Product Codes
HRS   HWC  
Date Received 08/24/2011
Decision Date 12/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No