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 ankle fusion cage
Regulation Description Intramedullary fixation rod.
Definition Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use.
Physical State Cylinder, spherical or rectangular box made of metal with open space throughout.
Technical Method Acts as a structural spacer and is used as an accessory to a tibiotalocalcaneal IM rod.
Target Area Ankle
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeSAI
Premarket Review Joint Arthroplasty Devices (DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3020
Device Class 2
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
-
-