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 K263083
Device Name Response Ortho Smart Fixator - Hexapod System
Applicant
Response Ortho Solutions, LLC
1875 W Woolbright Rd.
Boynton Beach,  FL  33426
Applicant Contact ISIN Sehmuz
Correspondent
Regulatory Insight, Inc.
16958 Long Winding Rd.
Morrison,  CO  80465
Correspondent Contact Kevin Walls
Regulation Number888.3030
Classification Product Code
KTT  
Date Received09/02/2026
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-