SYNMESH System— 510(k) K183054

Name: FDA 510(k) clearance K183054
Creator: U.S. Food and Drug Administration
Published: 2019-05-23

Substantially Equivalent

Depuy Synthes Spine

FDA 510(k) clearance K183054 for SYNMESH System, Substantially Equivalent on 2019-05-23. Applicant: Depuy Synthes Spine. Device class: 2.

Clearance details

Applicant: Depuy Synthes Spine
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2018-11-02
Decision date: 2019-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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.