510(k) clearance

GANNET®

FDA 510(k) source

510(k) number

K262184

Applicant

BAAT Medical Products B.V.

Decision date

Oct 22, 2026

Date received

Jun 29, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

JDO

Device type

Device, Fixation, Proximal Femoral, Implant

Device class

Class II

Regulation

21 CFR 888.3030

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Hengelo, NL