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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, toe, hemi-, phalangeal
Regulation Description Toe joint phalangeal (hemi-toe) polymer prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKWD
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3730
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review Not Third Party Eligible
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