MICROSUTURE ANCHORS


Device Classification Name

screw, fixation, bone

510(k) Number K112237
Device Name MICROSUTURE ANCHORS
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
HWC  
Subsequent Product Codes
MAI   MBI  
Date Received 08/04/2011
Decision Date 09/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No