Exactech Ambassador— 510(k) K143576

Clearance details

Applicant

Exactech, Inc.

Product code

Code KWQ

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2014-12-17

Decision date

2015-02-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gainesville, FL, US

• K261309 — Palisades Buttress Plate System2026-07-16
• K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
• K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
• K260570 — corra cervical plating system2026-04-22
• K260697 — VyPlate Anterior Cervical Plate System2026-03-27

• 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

Death

8

Injury

1,212

Malfunction

1,233

Total

2,453

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 →

• Z-2071-2015 — Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.Class II·Terminated·Exactech, Inc.·20150521

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143576.