Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K012938
Device Name SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Applicant Contact TRUDE C NAFF
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Correspondent Contact TRUDE C NAFF
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/31/2001
Decision Date 02/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-