510(k) clearance

ArthroTAK Tendon Anchor Kit

FDA 510(k) source

510(k) number

K262809

Applicant

ArthroTAK, LLC

Decision date

Sep 2, 2026

Date received

Aug 7, 2026

Decision

Substantially Equivalent

Clearance type

Special

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

Missoula, MT, US