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 Pin, Fixation, Smooth
510(k) Number K010983
Device Name PLLA PIN
Applicant
Bionx Implants, Inc.
Hermiankatu 6-8 L
Tampere,  FI FIN-33720
Applicant Contact TUIJA ANNALA
Correspondent
Bionx Implants, Inc.
Hermiankatu 6-8 L
Tampere,  FI FIN-33720
Correspondent Contact TUIJA ANNALA
Regulation Number888.3040
Classification Product Code
HTY  
Date Received04/02/2001
Decision Date 06/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-