ExactechGPS Total Shoulder Application— 510(k) K173372

Clearance details

Applicant

Blue Ortho

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2017-10-27

Decision date

2017-11-24

Decision

Substantially Equivalent

Clearance type

Special

Location

Gieres, FR

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• K233299 — ExactechGPS® System2024-01-26
• K232521 — ExactechGPS® Total Ankle Application2023-11-16
• K213877 — ExactechGPS® System2022-05-02
• K213546 — ExactechGPS Total Shoulder Application, Equinoxe Planning Software2022-01-06
• K193618 — ExactechGPS System2020-09-02

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

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-2050-2023 — Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.Class II·Ongoing·Exactech, Inc.·20230605

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173372.