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 filler, bone void, calcium compound containing single approved aminoglycoside
De Novo Number DEN210044
Device Name CERAMENT G
Requester
BoneSupport AB
scheelevagen 19, ideon science park
lund,  SE se 223-70
Contact blerta shuka
Regulation Number888.3046
Classification Product Code
QRR  
Date Received09/28/2021
Decision Date 05/17/2022
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Reclassification Order Reclassification Order
Type Direct
-
-