SYPMHONY OCT System— 510(k) K192014

Clearance details

Applicant

Medos International SARL

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2019-07-29

Decision date

2020-01-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lelocle, CH

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• K260240 — SYMPHONY Navigation Ready Instruments2026-03-27
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• K243249 — TriALTIS Spine System2025-01-17
• K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays2024-09-16

Death

15

Injury

1,090

Malfunction

529

Total

1,634

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 →