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Trade Name | Patient Specific Talus Trial |
Classification Name | prosthesis, total talus replacement, metal |
Generic Name | prosthesis, total talus replacement, metal |
Applicant |
Paragon 28, Inc. |
14445 grasslands dr. |
englewood, CO 80112 |
|
HDE Number | H200001 |
Supplement Number | S004 |
Date Received | 12/06/2022 |
Decision Date | 02/02/2023 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding patient specific talus instrument trial to the patient specific talus spacer. |