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Device
prosthesis, shoulder, constrained, metal/metal or metal/polymer cemented
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 Code
KWR
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
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
11-330 ASTM F2028-17
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
11-334 ASTM F1829-17
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
11-360 ASTM F1378-18e1
Standard Specification for Shoulder Prostheses
Third Party Review
Not Third Party Eligible
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