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 K003641
Device Name BIOLOK SCREW, BIOSTEON SCREW
Applicant
Biocomposites, Ltd.
Etruscan St., Etruria
Stoke On Trent,  GB ST1 5PQ
Applicant Contact J.STEPHEN BRATT
Correspondent
Biocomposites, Ltd.
Etruscan St., Etruria
Stoke On Trent,  GB ST1 5PQ
Correspondent Contact J.STEPHEN BRATT
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/27/2000
Decision Date 02/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-