Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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Trade Name | Patient Specific Talus Spacer |
Classification Name | prosthesis, total talus replacement, metal |
Generic Name | prosthesis, total talus replacement, metal |
Applicant |
Paragon 28, Inc. |
14445 grasslands dr. |
englewood, CO 80112 |
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HDE Number | H200001 |
Supplement Number | S002 |
Date Received | 07/20/2021 |
Decision Date | 01/14/2022 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the protocol of the post-approval study that paragon 28, inc. Agreed to conduct as part of the conditions of approval for the patient specific talus spacer (h200001 for cocr version and h200001/s001 for ti6al4v with tin coating version), approved on february 17, 2021 for h200001 and december 10, 2021 for h200001/s001. |
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