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

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device prosthesis, total talus replacement with soft tissue attachment sites, metal
Definition Replaces the native talus
Physical State Solid metallic device with soft tissue attachment sites and not fixed to bones
Technical Method Placed between the distal tibia and calcaneus with soft tissues attached
Target Area Talus
Review Panel Orthopedic
Product CodeQYQ
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-