Device Classification Name |
fastener, fixation, biodegradable, soft tissue
|
510(k) Number |
K240090 |
Device Name |
Argo Knotless GENESYS Anchor |
Applicant |
CONMED Corporation |
525 French Road |
Utica,
NY
13502
|
|
Applicant Contact |
Dionne Sanders |
Correspondent |
CONMED Corporation |
525 French Road |
Utica,
NY
13502
|
|
Correspondent Contact |
Dionne Sanders |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/12/2024 |
Decision Date | 03/05/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|