Romeo posterior osteosynthesis system— 510(k) K151695

Name: FDA 510(k) clearance K151695
Creator: U.S. Food and Drug Administration
Published: 2015-09-10

Substantially Equivalent

Spineart

FDA 510(k) clearance K151695 for Romeo posterior osteosynthesis system, Substantially Equivalent on 2015-09-10. Applicant: Spineart. Device class: 2.

Clearance details

Applicant: Spineart
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2015-06-23
Decision date: 2015-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

Download summary PDF View on FDA.gov ↗

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K203506 — PERLA® TL posterior osteosynthesis system2021-01-15
K203222 — PERLA TL Posterior Osteosynthesis System2020-12-17

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.