MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR— 510(k) K070925
Substantially EquivalentDepuy Mitek, A Johnson & Johnson Company
FDA 510(k) clearance K070925 for MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR, Substantially Equivalent on 2007-05-02. Applicant: Depuy Mitek, A Johnson & Johnson Company.
Clearance details
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
- Product code
- Code MAI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Raynham, MA, US
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.