ARTHREX INTERFERENCE SCREW— 510(k) K062466
Substantially EquivalentArthrex, Inc.
FDA 510(k) clearance K062466 for ARTHREX INTERFERENCE SCREW, Substantially Equivalent on 2006-11-29. Applicant: Arthrex, Inc..
Clearance details
- Applicant
- Arthrex, Inc.
- Product code
- Code MAI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Naples, FL, 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.