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Device
prosthesis, shoulder, humeral (bipolar hemi-shoulder) metal/polymer, cemented or uncemented
Review Panel
Orthopedic
Product Code
MJT
Premarket Review
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type
Contact ODE
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
11-342 ASTM F732-17
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
11-360 ASTM F1378-18e1
Standard Specification for Shoulder Prostheses
Third Party Review
Not Third Party Eligible
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