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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCARTIVA SYNTHETIC CARTILAGE IMPLANT
Generic NameProsthesis, metatarsophalangeal joint cartilage replacement implant
ApplicantCartiva, Inc
6120 Windward Parkway
Suite 220
Alpharetta, GA 30005
PMA NumberP150017
Date Received05/01/2015
Decision Date07/01/2016
Product Code PNW 
Docket Number 16M-1916
Notice Date 07/08/2016
Advisory Committee Orthopedic
Clinical TrialsNCT00969969
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for use in the treatment of patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 
-
-