BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B


Device Classification Name

washer, bolt nut

510(k) Number K023119
Device Name BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
Original Applicant
ARTHREX, INC.
2885 south horseshoe dr.
naples, 
FL 
34104

Original Contact ann waterhouse
Regulation Number 888.3030
Classification Product Code
HTN  
Subsequent Product Code
HWC  
Date Received 09/19/2002
Decision Date 12/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No