• 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 screw, fixation, bone
510(k) Number K111001
Device Name STERILE STORM (R) OPERATING KIT
Applicant
INTELLIGENT ORTHOPAEDICS LTD
STAFFORDSHIRE UNIVERSITY
BUSINESS VILLAGE, LEEK ROAD
stoke on trent, staffordshire,  GB st4 2ar
Applicant Contact peter j ogrodnik
Correspondent
INTELLIGENT ORTHOPAEDICS LTD
STAFFORDSHIRE UNIVERSITY
BUSINESS VILLAGE, LEEK ROAD
stoke on trent, staffordshire,  GB st4 2ar
Correspondent Contact peter j ogrodnik
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTY  
Date Received04/11/2011
Decision Date 05/17/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-