PCL TIGHTROPE


Device Classification Name

pin, fixation, smooth

510(k) Number K110123
Device Name PCL TIGHTROPE
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
HTY  
Subsequent Product Code
GAT  
Date Received 01/18/2011
Decision Date 04/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No