Revolution External Plating System— 510(k) K181630
Substantially EquivalentNew Standard Device Dba Metalogix
FDA 510(k) clearance K181630 for Revolution External Plating System, Substantially Equivalent on 2019-05-29. Applicant: New Standard Device Dba Metalogix.
Clearance details
- Applicant
- New Standard Device Dba Metalogix
- Product code
- Code KTT
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Adverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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.