510(k) K251530

CONMED Argo Knotless® Anchor by Conmed Corporation — Product Code MBI

K251530 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "CONMED Argo Knotless® Anchor". The FDA issued a decision of Substantially Equivalent on June 18, 2025. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Conmed Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
May 19, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type