510(k) K223318

Device

Internal Joint Stabilizer - Elbow

Applicant

Skeletal Dynamics, Inc.

510(k) number

K223318

Product code

OZI

Decision

Substantially Equivalent (SESE)

Decision date

2023-05-10

Date received

2022-10-28

Regulation

888.3030

Classification name

Internal Hinged Elbow Fixator

Medical specialty

Orthopedic

Review panel

Orthopedic

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N

Source

FDA openFDA 510(k) dataset plus migrated FDA.report data