Exactech Equinoxe Stemless Shoulder— 510(k) K173388

Name: FDA 510(k) clearance K173388
Creator: U.S. Food and Drug Administration
Published: 2018-03-09

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K173388 for Exactech Equinoxe Stemless Shoulder, Substantially Equivalent on 2018-03-09. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code PKC
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2017-10-30
Decision date: 2018-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKC

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K254154 — FX V135 EASYTECH® Shoulder System2026-05-01
K252129 — AETOS Shoulder System Stemless Humeral Prosthesis2025-10-03
K243248 — INHANCE INTACT2024-12-23
K241873 — OsseoFit Stemless Shoulder System2024-12-11
K240716 — AETOS Shoulder System Stemless Humeral Prosthesis2024-11-20

More clearances from Exactech, Inc.

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K260583 — Equinoxe® Shoulder System2026-04-14
K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
K243448 — Equinoxe® Shoulder System2025-08-01
K243275 — Equinoxe® Scapula Fracture System2025-06-26
K243839 — Alteon® HA Femoral Stems2025-03-10

Adverse events under product code PKC

product code PKC

Injury: 258
Total: 258

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.