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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, knee, femorotibial, semi-constrained, cemented, metal/composite
Regulation Description Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKYK
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type 510(k)
Regulation Number 888.3500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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