510(k) K231278

Knotless Suture Anchor by Riverpoint Medical, LLC — Product Code MBI

K231278 is an FDA 510(k) premarket notification submitted by Riverpoint Medical, LLC for the device "Knotless Suture Anchor". The FDA issued a decision of Substantially Equivalent on August 1, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Riverpoint Medical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2023
Date Received
May 3, 2023
Clearance Type
Traditional
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