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 Plate, Bone
510(k) Number K011569
Device Name BIOSORBFX O/M 2.0/2/4 SYSTEM
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 Number872.4760
Classification Product Code
JEY  
Date Received05/21/2001
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-