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 Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K210498
Device Name Betta Link Knotless Implant System
Applicant
T.A.G. Medical Products Corporation, Ltd.
Gaaton
Gaaton,  IL 2513000
Applicant Contact Shlomi Dines
Correspondent
T.A.G. Medical Products Corporation, Ltd.
Gaaton
Gaaton,  IL 2513000
Correspondent Contact Anat Rozen
Regulation Number888.3040
Classification Product Code
MBI  
Date Received02/22/2021
Decision Date 03/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-