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Trade Name | restor3d Total Talus Replacement |
Classification Name | prosthesis, total talus replacement, metal |
Generic Name | prosthesis, total talus replacement, metal |
Applicant |
restor3d, Inc. |
311 w. corporation street |
durham, NC 27701 |
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HDE Number | H230003 |
Supplement Number | S001 |
Date Received | 12/14/2023 |
Decision Date | 01/12/2024 |
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 of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for h230003 (restor3d total talus replacement). |