SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K110069
Device Name SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact shereen myers
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact shereen myers
Regulation Number 888.3030
Classification Product Code
KTT  
Subsequent Product Code
OSN  
Date Received 01/10/2011
Decision Date 02/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No