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Device
prosthesis, hip, hemi-, femoral, metal ball
Regulation Description
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
LZY
Premarket Review
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type
510(k)
Regulation Number
888.3360
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
11-395 ASTM F1814-22
Standard Guide for Evaluating Modular Hip and Knee Joint Components
11-401 ISO 21535 Third edition 2023-07
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
Guidance Document
Non-clinical Information for Femoral Stem Prostheses
Third Party Review
Not Third Party Eligible
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