ARTHREX BIOCOMPOSITE SUTURETAK


Device Classification Name

fastener, fixation, biodegradable, soft tissue

510(k) Number K110660
Device Name ARTHREX BIOCOMPOSITE SUTURETAK
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
MAI  
Subsequent Product Code
HWC  
Date Received 03/07/2011
Decision Date 03/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No