510(k) K233730

Footprint Mini PK, 3.5mm Suture Anchor by Smith & Nephew — Product Code MBI

K233730 is an FDA 510(k) premarket notification submitted by Smith & Nephew for the device "Footprint Mini PK, 3.5mm Suture Anchor". The FDA issued a decision of Substantially Equivalent on January 17, 2024. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2024
Date Received
November 21, 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