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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeMEH
Premarket Review Orthopedic Devices (OHT6)
Joint Anthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3353
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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