ARTHREX SCAPHOLUNATE ANCHOR


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K111661
Device Name ARTHREX SCAPHOLUNATE ANCHOR
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 888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received 06/14/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No