Cleared Traditional

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws

K223933 · Exactech, Inc. · Orthopedic
Sep 2023
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K223933 is an FDA 510(k) clearance for the Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on September 25, 2023, 269 days after receiving the submission on December 30, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K223933 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2022
Decision Date September 25, 2023
Days to Decision 269 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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