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 Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K203393
Device Name FAST-FIX FLEX
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Applicant Contact Crystal Morales
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova,  TN  38016
Correspondent Contact Crystal Morales
Regulation Number878.5000
Classification Product Code
GAT  
Date Received11/18/2020
Decision Date 02/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-