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 sacroiliac joint fixation
510(k) Number K223819
Device Name SI-Cure Sacroiliac Joint Fusion System
Applicant
Alevio, LLC
200 Cahaba Park, Suite 100
Birmingham,  AL  35242
Applicant Contact Trey Robbins
Correspondent
Empirical Technologies
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3040
Classification Product Code
OUR  
Date Received12/21/2022
Decision Date 01/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-