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 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K241563
Device Name Extremity Medical External Fixation System
Applicant
Extremity Medical, LLC
300 Interpace Pkwy.
Bldg. A, 2nd Floor
Parsippany,  NJ  07054
Applicant Contact Mary Hoffman
Correspondent
Extremity Medical, LLC
300 Interpace Pkwy.
Bldg. A, 2nd Floor
Parsippany,  NJ  07054
Correspondent Contact Mary Hoffman
Regulation Number888.3030
Classification Product Code
KTT  
Date Received05/31/2024
Decision Date 02/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-