510(k) K093361— SYNTHES AIR PEN DRIVE (APD) SYSTEM

Substantially Equivalent

Synthes (Usa)

Clearance details

Applicant: Synthes (Usa)
Product code: Code HBB
Advisory panel: Neurology
Date received: 2009-10-28
Decision date: 2010-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

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.