|
Trade Name | SR MCP System |
Classification Name | semi-constrained metal/polymer finger joint prosthesis |
Generic Name | semi-constrained metal/polymer finger joint prosthesis |
Applicant |
Encore Medical L/P. d/b/a DJO Surgical |
9800 metric boulevard |
austin, TX 78758 |
|
HDE Number | H010001 |
Supplement Number | S005 |
Date Received | 02/26/2021 |
Decision Date | 04/11/2021 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at sterigenics belgium petit rechain s. A. , avenue andre ernst 21verviers liege be, for sterilization procedures. |