POSEIDON ST— 510(k) K261031

Name: FDA 510(k) clearance K261031
Creator: U.S. Food and Drug Administration
Published: 2026-07-10

Substantially Equivalent

Signus Medinzintechnik GmbH

FDA 510(k) clearance K261031 for POSEIDON ST, Substantially Equivalent on 2026-07-10. Applicant: Signus Medinzintechnik GmbH. Device class: 2.

Clearance details

Applicant: Signus Medinzintechnik GmbH
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2026-03-30
Decision date: 2026-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alzenau, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQP

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K261810 — Vertiwedge® Intraosseous System2026-07-31
K253158 — VyBrate VBR System2026-01-07
K241468 — Vertiwedge® Intraosseous System2024-11-07
K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04
K233359 — DOMINION Expandable Corpectomy System2024-03-08

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.