510(k) K253764

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

February 26, 2026

Date Received

November 25, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Software For Diagnosis/Treatment

Device Class

Class II

Regulation Number

888.3030

Review Panel

OR

Submission Type

Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions