Ball Joint Guide Array (66295)— 510(k) K250893
Substantially EquivalentBayer Medical Care, Inc.
FDA 510(k) clearance K250893 for Ball Joint Guide Array (66295), Substantially Equivalent on 2025-09-04. Applicant: Bayer Medical Care, Inc..
Clearance details
- Applicant
- Bayer Medical Care, Inc.
- Product code
- Code HAW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianaola, PA, US
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . 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.