K192995
Substantially EquivalentOsteoRemedies Hip Spacer System
- Applicant
- Osteoremedies, LLC
- Product code
- KWL
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Germantown, TN, US
Adverse events under product code KWL
product code KWL- Injury
- 523
- Total
- 523
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.