|
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 | S003 |
Date Received | 11/21/2022 |
Decision Date | 12/19/2022 |
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 of the revised protocol for the post-approval study (pas) referenced above. |