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.

Summary

Signus's POSEIDON ST is filed under MQP, spinal vertebral body replacement devices. The record doesn't expand "ST" or give sizes.

Class II, 21 CFR 888.3060. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Signus filed from Alzenau, Germany. The decision came 102 calendar days after receipt (March 30 to July 10, 2026).

Clearance details

Applicant: Signus Medinzintechnik GmbH
Product code: Product 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 ↗

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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.