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U.S. Department of Health and Human Services

Product Classification

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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 Joint Arthroplasty Devices (DHT6A)
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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible