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 Staple, Absorbable
510(k) Number K011172
Device Name ARTHREX BIO-TRANSFIX
Applicant
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES,  FL  34104
Applicant Contact VERNON BROWN
Correspondent
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES,  FL  34104
Correspondent Contact VERNON BROWN
Regulation Number888.3030
Classification Product Code
MNU  
Subsequent Product Codes
HTY   JDR  
Date Received04/17/2001
Decision Date 06/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-