510(k) K231447

Device

Double Internal Joint Stabilizer- Elbow

Applicant

Skeletal Dynamics, Inc.

510(k) number

K231447

Product code

OZI

Decision

Substantially Equivalent (SESE)

Decision date

2023-12-15

Date received

2023-05-18

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