COSMIC SYSTEM— 510(k) K080841
Substantially EquivalentUlrich GmbH & Co. KG
FDA 510(k) clearance K080841 for COSMIC SYSTEM, Substantially Equivalent on 2008-07-23. Applicant: Ulrich GmbH & Co. KG.
Clearance details
- Applicant
- Ulrich GmbH & Co. KG
- Product code
- Code MNI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Adverse events under product code MNI
product code MNI- Injury
- 641
- Total
- 641
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.