Cleared Traditional

Equinoxe? Scapula Fracture System

K243275 · Exactech, Inc. · Orthopedic
Jun 2025
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K243275 is an FDA 510(k) clearance for the Equinoxe? Scapula Fracture System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on June 26, 2025, 253 days after receiving the submission on October 16, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243275 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 2024
Decision Date June 26, 2025
Days to Decision 253 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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