ARTHREX COMPRESSION STAPLE


Device Classification Name

staple, fixation, bone

510(k) Number K080111
Device Name ARTHREX COMPRESSION STAPLE
Applicant
ARTHREX, INC.
1370 creekside blvd.
naples, 
FL 
34108 -1945

Applicant Contact sally foust
Correspondent
ARTHREX, INC.
1370 creekside blvd.
naples, 
FL 
34108 -1945

Correspodent Contact sally foust
Regulation Number 888.3030
Classification Product Code
JDR  
Date Received 01/16/2008
Decision Date 02/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No