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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K100107
Device Name SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact REGINA HOLMES
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact REGINA HOLMES
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/14/2010
Decision Date 02/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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