PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT— 510(k) K140900
Substantially EquivalentStanmore Worldwide Implants , Ltd.
FDA 510(k) clearance K140900 for PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT, Substantially Equivalent on 2015-02-12. Applicant: Stanmore Worldwide Implants , Ltd..
Clearance details
- Applicant
- Stanmore Worldwide Implants , Ltd.
- Product code
- Code KRO
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plymouth, MA, US
Adverse events under product code KRO
product code KRO- Death
- 19
- Injury
- 4,841
- Total
- 4,860
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.