Cleared Traditional

Footprint Mini PK, 3.5mm Suture Anchor

K233730 · Smith & Nephew · Orthopedic
Jan 2024
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K233730 is an FDA 510(k) clearance for the Footprint Mini PK, 3.5mm Suture Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Smith & Nephew (Andover, US). The FDA issued a Cleared decision on January 17, 2024, 57 days after receiving the submission on November 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K233730 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2023
Decision Date January 17, 2024
Days to Decision 57 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040