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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, toe, constrained, polymer
Regulation Description Toe joint polymer constrained prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKWH
Premarket Review Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3720
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
Third Party Review Not Third Party Eligible
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