Exactech Equinoxe Small Reverse Shoulder System— 510(k) K180632
Substantially EquivalentExactech, Inc.
FDA 510(k) clearance K180632 for Exactech Equinoxe Small Reverse Shoulder System, Substantially Equivalent on 2018-07-25. Applicant: Exactech, Inc.. Device class: 2.
Clearance details
- Applicant
- Exactech, Inc.
- Product code
- Code PHX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gainesville, FL, US
Recent devices under product code PHX
view allMore clearances from Exactech, Inc.
view allAdverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K180632
K-number listed on FDA's recall record- Z-1420-2024 — Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
- Z-1421-2024 — Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
- Z-0579-2024 — Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46-13
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180632.
Data sourced from openFDA. This site is unofficial and independent of the FDA.