SURGICAL TITANIUM MESH SYSTEM— 510(k) K003043

Substantially Equivalent

Depuyacromed

FDA 510(k) clearance K003043 for SURGICAL TITANIUM MESH SYSTEM, Substantially Equivalent on 2001-05-08. Applicant: Depuyacromed.

Clearance details

Applicant: Depuyacromed
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2000-09-29
Decision date: 2001-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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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.