510(k) clearance

Aevumed SUPERCYNCH™ Button System

FDA 510(k) source

510(k) number

K253065

Applicant

Aevumed, Inc.

Decision date

Sep 2, 2026

Date received

Sep 22, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MBI

Device type

Fastener, Fixation, Nondegradable, Soft Tissue

Device class

Class II

Regulation

21 CFR 888.3040

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Malvern, PA, US