510(k) K240090

Argo Knotless GENESYS Anchor by Conmed Corporation — Product Code MAI

K240090 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "Argo Knotless GENESYS Anchor". The FDA issued a decision of Substantially Equivalent on March 5, 2024. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Conmed Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2024
Date Received
January 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type