MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw— 510(k) K240441
Substantially EquivalentDepuy Mitek
FDA 510(k) clearance K240441 for MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw, Substantially Equivalent on 2024-03-15. Applicant: Depuy Mitek. Device class: 2.
Clearance details
- Applicant
- Depuy Mitek
- Product code
- Code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Raynham, MA, US
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Adverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
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.