START JUNIOR— 510(k) K073512

Substantially Equivalent

Otto Bock Healthcare LP

FDA 510(k) clearance K073512 for START JUNIOR, Substantially Equivalent on 2008-01-14. Applicant: Otto Bock Healthcare LP.

Clearance details

Applicant: Otto Bock Healthcare LP
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2007-12-14
Decision date: 2008-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.