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, biodegradable, soft tissue
510(k) Number K173788
Device Name Arthrex Corkscrew FT
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Napes,  FL  34108 -1945
Applicant Contact David L Rogers
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact David L Rogers
Regulation Number888.3030
Classification Product Code
MAI  
Date Received12/14/2017
Decision Date 03/01/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-