SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1


Device Classification Name

orthopedic stereotaxic instrument

510(k) Number K110240
Device Name SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
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 882.4560
Classification Product Code
OLO  
Date Received 01/27/2011
Decision Date 04/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No