ARTHREX BIOCOMPOSITE TRANSFIX


Device Classification Name

fastener, fixation, biodegradable, soft tissue

510(k) Number K112040
Device Name ARTHREX BIOCOMPOSITE TRANSFIX
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
MAI  
Subsequent Product Code
HWC  
Date Received 07/18/2011
Decision Date 12/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No