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

Premarket Approval (PMA)
  • 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceInfuse (R) Bone Graft
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000058
Supplement NumberS065
Date Received04/28/2017
Decision Date09/21/2017
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for expansion of the approved indications for use of Infuse Bone Graft to include implantation with two additional interbody fusion devices, the Divergence-L Anterior/Oblique Lumbar Fusion System or the Pivox Oblique Lateral Spinal System, utilizing select open surgical procedures in conjunction with supplemental spinal fixation hardware, as well as modifying the surgical technique manual to allow surgeons to optionally wrap a resorbable suture around the fusion cage component to maintain the position of the Infuse Bone Graft within the central cavity of the fusion cage component.
-
-