SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K122170
Device Name SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
Applicant
SMITH & NEPHEW, INC.
7135 goodlett farms parkway
cordova, 
TN 
38016

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

Correspodent Contact bradley heil
Regulation Number 888.3020
Classification Product Code
HSB  
Subsequent Product Codes
HWC   JDS   KTT  
Date Received 07/23/2012
Decision Date 10/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No