510(k) clearance

Wishbone HAE

FDA 510(k) source

510(k) number

K260096

Applicant

Wishbone SA

Decision date

Oct 9, 2026

Date received

Jan 13, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NPM

Device type

Bone Grafting Material, Animal Source

Device class

Class II

Regulation

21 CFR 872.3930

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Flémalle, BE