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 K200696
Device Name FIREBIRD SI Fusion System
Applicant
Orthofix Inc.
3451 Plano Parkway
Lewisville,  TX  75056
Applicant Contact Jacki Koch
Correspondent
Orthofix Inc.
3451 Plano Parkway
Lewisville,  TX  75056
Correspondent Contact Jacki Koch
Regulation Number888.3040
Classification Product Code
OUR  
Date Received03/17/2020
Decision Date 04/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-