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 Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
510(k) Number K243843
Device Name Tendon Protect (50242)
Applicant
Kerecis Limited
Sundstraeti 38, 400 Isafjordur
P.O. Box 151
Isafjordur,  IS 400
Applicant Contact Skuli Magnusson
Correspondent
Kerecis Limited
Sundstraeti 38, 400 Isafjordur
P.O. Box 151
Isafjordur,  IS 400
Correspondent Contact Skuli Magnusson
Regulation Number878.3300
Classification Product Code
OWY  
Subsequent Product Code
FTM  
Date Received12/13/2024
Decision Date 06/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-