The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Argo Knotless Sp Anchor.
Device ID | K220757 |
510k Number | K220757 |
Device Name: | Argo Knotless SP Anchor |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | CONMED Corporation 525 French Road Utica, NY 13502 |
Contact | Dionne Sanders |
Correspondent | Dionne Sanders CONMED Corporation 525 French Road Utica, NY 13502 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-15 |
Decision Date | 2022-05-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854649869 | K220757 | 000 |
20845854649814 | K220757 | 000 |