DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional— 510(k) K183472
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K183472 for DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional, Substantially Equivalent on 2019-03-13. Applicant: Synthes (USA) Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes (USA) Products, LLC
- Product code
- Code FTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
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Adverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
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.