REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement— 510(k) K172906
Substantially EquivalentOsteoremedies, LLC
FDA 510(k) clearance K172906 for REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement, Substantially Equivalent on 2018-08-29. Applicant: Osteoremedies, LLC.
Clearance details
- Applicant
- Osteoremedies, LLC
- Product code
- Code KWL
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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.