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 K003756
Device Name BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES
Applicant
Bionx Implants, Inc.
1777 Sentry Pkwy. W.
Gwynedd Hall,Suite 400
Blue Bell,  PA  19422
Applicant Contact DAVID W ANDERSON
Correspondent
Bionx Implants, Inc.
1777 Sentry Pkwy. W.
Gwynedd Hall,Suite 400
Blue Bell,  PA  19422
Correspondent Contact DAVID W ANDERSON
Regulation Number872.4760
Classification Product Code
JEY  
Date Received12/06/2000
Decision Date 01/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-