EQUINOXE EXTRA SHORT HUMERAL HEAD— 510(k) K140063

Name: FDA 510(k) clearance K140063
Creator: U.S. Food and Drug Administration
Published: 2014-02-11

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K140063 for EQUINOXE EXTRA SHORT HUMERAL HEAD, Substantially Equivalent on 2014-02-11. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2014-01-10
Decision date: 2014-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 02025-10-29
K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

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 KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.