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.
 
Deviceprodisc - C and prodisc - C Nova (Indicated for Single Level Use)
Generic NameProsthesis, intervertebral disc
ApplicantCentinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
PMA NumberP070001
Supplement NumberS026
Date Received02/06/2024
Decision Date03/01/2024
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for modification to the device labeling to include the addition of the following precaution statement: “Precaution: The safety and effectiveness of the prodisc C, when implanted at more than one cervical spinal level and/or adjacent to an anterior cervical discectomy and fusion (ACDF) has not been established.”
-
-