|
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 |
|
HDE Number | H200001 |
Supplement Number | S005 |
Date Received | 02/09/2024 |
Decision Date | 04/19/2024 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to the addition of a manufacturing process step (hot isostatic pressing - hip) and a change to the in-process limits for the titanium with titanium nitride surface coating version of the subject device. |