510(k) K984585— OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE

Substantially Equivalent

Osteonics Corp.

Clearance details

Applicant: Osteonics Corp.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1998-12-24
Decision date: 1999-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.