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 screw, fixation, bone
510(k) Number K222564
Device Name Treace Medical Concepts (TMC) Hammertoe Fixation System
Applicant
Treace Medical Concepts, Inc.
203 Fort Wade Rd.
Suite 150
Ponte Vedra,  FL  32081
Applicant Contact Kristina Hall
Correspondent
MRC Global
9085 E. Mineral Circle, Suite 110
Centennial,  CO  80112
Correspondent Contact Danielle Besal
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/24/2022
Decision Date 11/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-