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

Humanitarian Device Exemption (HDE)
  • 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 supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade Name4WEB Medical Talar Replacement Device
Classification Nameprosthesis, total talus replacement, metal
Generic Nameprosthesis, total talus replacement, metal
Applicant
Stryker
1023 cherry rd.
memphis, TN 38117
HDE NumberH240001
Supplement NumberS002
Date Received10/01/2025
Decision Date10/31/2025
Product Code
QNN[ Registered Establishments with QNN ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to place on hold the post-approval study (pas) for the 4web medical talar replacement device since you are no longer pursuing commercialization or distribution of the subject device.
-
-