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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, shoulder, semi-constrained, metal/polymer cemented
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKWS
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3660
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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