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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Regulation Description Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKRO
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 888.3510
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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