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 intervertebral fusion device with bone graft, lumbar
510(k) Number K190544
Device Name XIHPOS™ ZFUZE™ Interbody Fusion System
Applicant
DiFusion Technologies
1624 Headway Circle
Austin,  TX  78754
Applicant Contact Derrick Johns
Correspondent
Hogan Lovells
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MPQ  
Date Received03/04/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-