SMITH & NEPHEW CANNULATED SCREWS AND WASHERS


Device Classification Name

screw, fixation, bone

510(k) Number K111994
Device Name SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
Applicant
SMITH & NEPHEW, INC.
7135 goodlett farms parkway
cordova, 
TN 
38016

Applicant Contact maureen whitson
Correspondent
SMITH & NEPHEW, INC.
7135 goodlett farms parkway
cordova, 
TN 
38016

Correspodent Contact maureen whitson
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
NDG  
Date Received 07/13/2011
Decision Date 10/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No