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Trade Name | restor3d Total Talus Replacement (TTR) Implant |
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 | S002 |
Date Received | 01/17/2024 |
Decision Date | 02/08/2024 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modifications to the inspection dimension b on the subject device, which changes the plane in which the mediolateral dimension is taken, and visual inspection to a calibrated polishing block for inspection of the light polished non-articulating areas. |