• 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 talus spacer
Definition Replaces the native talus
Physical State Solid metallic device that is free-floating (not fixed to any bone or soft tissue)
Technical Method Placed between the distal tibia and calcaneous
Target Area Ankle Joint
Review Panel Orthopedic
Product CodeQNN
Premarket Review 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
-
-