Cleared Traditional

K240835 - Suture Button Repair System
(FDA 510(k) Clearance)

K240835 · Skeletal Dynamics, Inc. · Orthopedic
Jul 2024
Decision
115d
Days
Class 2
Risk

K240835 is an FDA 510(k) clearance for the Suture Button Repair System, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on July 19, 2024, 115 days after receiving the submission on March 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K240835 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2024
Decision Date July 19, 2024
Days to Decision 115 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