510(k) K183054— SYNMESH System

Substantially Equivalent

Depuy Synthes Spine

Clearance details

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

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.