Catalyst CSR Shoulder System— 510(k) K181287
Substantially EquivalentCatalyst Orthoscience, Inc.
FDA 510(k) clearance K181287 for Catalyst CSR Shoulder System, Substantially Equivalent on 2018-07-12. Applicant: Catalyst Orthoscience, Inc..
Clearance details
- Applicant
- Catalyst Orthoscience, Inc.
- Product code
- Code KWT
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Naples, FL, US
Adverse events under product code KWT
product code KWT- Injury
- 2,467
- Other
- 2
- Total
- 2,469
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.