VERTEBRAL SPACER— 510(k) K011037

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K011037 for VERTEBRAL SPACER, Substantially Equivalent on 2002-07-01. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2001-04-05
Decision date: 2002-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, 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.