OSTEO CERCLAGE WIRE— 510(k) K914374

Substantially Equivalent

Osteo AG

FDA 510(k) clearance K914374 for OSTEO CERCLAGE WIRE, Substantially Equivalent on 1991-12-30. Applicant: Osteo AG.

Clearance details

Applicant: Osteo AG
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 1991-10-01
Decision date: 1991-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood, SC, US

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Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.