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 washer, bolt nut
510(k) Number K220650
Device Name TriMed Ripcord Device
Applicant
TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita,  CA  91355
Applicant Contact David Medoff
Correspondent
Tech2Med, LLC
6450 Old Darby TRL NE
Ada,  MI  49301
Correspondent Contact David Anderson
Regulation Number888.3030
Classification Product Code
HTN  
Date Received03/07/2022
Decision Date 06/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-