Clavicle Fixation System— 510(k) K254288

Name: FDA 510(k) clearance K254288
Creator: U.S. Food and Drug Administration
Published: 2026-03-23

Substantially Equivalent

Skeletal Dynamics, Inc.

FDA 510(k) clearance K254288 for Clavicle Fixation System, Substantially Equivalent on 2026-03-23. Applicant: Skeletal Dynamics, Inc.. Device class: 2.

Summary

Skeletal Dynamics' Clavicle Fixation System is filed under HRS, bone fixation plates. The name is generic, and the record doesn't list components.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as an Abbreviated 510(k).

Skeletal Dynamics filed from Miami, Florida. Review took 82 calendar days (December 31, 2025 to March 23, 2026).

Clearance details

Applicant: Skeletal Dynamics, Inc.
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-12-31
Decision date: 2026-03-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.