PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0— 510(k) K083565
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K083565 for PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0, Substantially Equivalent on 2009-02-20. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Memphis, TN, US
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Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
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.