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 arthroplasty implantation system
Regulation Description Ankle joint metal/polymer semi-constrained cemented prosthesis.
Definition Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.
Physical State A device accessory or a set of device accessories.
Technical Method Aids the surgeon in performing the implantation of an ankle arthroplasty device.
Target Area Ankle
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOYK
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3110
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
-
-