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U.S. Department of Health and Human Services

Product Classification

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Device metallic cemented glenoid hemi-shoulder prosthesis
Regulation Description Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Definition Call for pmas to be filed by 12/26/96 per 61 fr 50711 on 9/27/96
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKYM
Premarket Review Joint Arthroplasty Devices (DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Regulation Number 888.3680
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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