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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 absorbable gel for intraoperative use in spine surgery
De Novo Number DEN240038
Device Name Oxiplex®
Requester
fziomed, inc.
231 bonetti dr.
san luis obispo,  CA  93401
Contact lisa gawehn
Regulation Number888.3047
Classification Product Code
QVL  
Date Received07/22/2024
Decision Date 06/17/2025
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-