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U.S. Department of Health and Human Services

Product Classification
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Device total shoulder arthroplasty system
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Definition To treat pain and lack of function in the shoulder.
Physical State Metallic humeral stem relying on threaded fixation
Technical Method Humeral head is resected and bone is prepared to accept humeral component
Target Area Shoulder, Proximal Humerus
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQHQ
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		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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