510(k) clearance

Trochlear Salvage Plating System

FDA 510(k) source

510(k) number

K261135

Applicant

Skeletal Dynamics, Inc.

Decision date

Oct 26, 2026

Date received

Apr 7, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

HRS

Device type

Plate, Fixation, Bone

Device class

Class II

Regulation

21 CFR 888.3030

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Miami, FL, US