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Device
prosthesis, elbow, hemi-, radial, polymer
Regulation Description
Elbow joint radial (hemi-elbow) polymer prosthesis.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
KWI
Premarket Review
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type
510(k)
Regulation Number
888.3170
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
11-197 ASTM F983-86 (Reapproved 2018)
Standard Practice for Permanent Marking of Orthopaedic Implant Components
11-199 ASTM F565-04 (Reapproved 2018)
Standard Practice for Care and Handling of Orthopedic Implants and Instruments
11-321 ASTM F2887-17
Standard Specification for Total Elbow Prostheses
11-404 ASTM F2887-23
Standard Specification for Total Elbow Prostheses
Third Party Review
Not Third Party Eligible
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