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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, shoulder, constrained, metal/metal or metal/polymer cemented
Regulation Description Shoulder joint metal/metal or metal/polymer constrained 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 CodeKWR
Premarket Review Joint Arthroplasty Devices (DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
Regulation Number 888.3640
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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