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 Orthopedic Stereotaxic Instrument
510(k) Number K092497
Device Name SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
Applicant
Smith & Nephew, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact REGINA HOLMES
Correspondent
Smith & Nephew, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact REGINA HOLMES
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/14/2009
Decision Date 09/11/2009
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
-
-