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 Screw, Fixation, Bone
510(k) Number K042295
Device Name SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
Applicant
Linvatec Biomaterials, Ltd.
Hermiankatu 6-8l
Tampere,  FI
Applicant Contact TUIJA ANNALA
Correspondent
Linvatec Biomaterials, Ltd.
Hermiankatu 6-8l
Tampere,  FI
Correspondent Contact TUIJA ANNALA
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/24/2004
Decision Date 09/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-