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 K201664
Device Name FIREBIRD SI Fusion System
Applicant
Orthofix, Inc.
3451 Plano Pkwy.
Lewisville,  TX  75056
Applicant Contact Jacki Koch
Correspondent
Orthofix, Inc.
3451 Plano Pkwy.
Lewisville,  TX  75056
Correspondent Contact Jacki Koch
Regulation Number888.3040
Classification Product Code
OUR  
Date Received06/19/2020
Decision Date 09/15/2020
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
-
-