510(k) K243323

Iconix Knotless Anchor by Riverpoint Medical — Product Code MBI

K243323 is an FDA 510(k) premarket notification submitted by Riverpoint Medical for the device "Iconix Knotless Anchor". The FDA issued a decision of Substantially Equivalent on November 19, 2024. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Riverpoint Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2024
Date Received
October 23, 2024
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