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U.S. Department of Health and Human Services

Product Classification
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Device spacer, cement
Regulation Description Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeLTO
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Regulation Number 888.3320
Device Class 3
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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