4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B


Device Classification Name

screw, fixation, bone

510(k) Number K020043
Device Name 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B
Original Applicant
ARTHREX, INC.
2885 south horseshoe dr.
naples, 
FL 
34104

Original Contact ann waterhouse
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 01/07/2002
Decision Date 04/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No