DePuy Synthes Radial Head Replacement System— 510(k) K213563
Substantially EquivalentDePuy Synthes
FDA 510(k) clearance K213563 for DePuy Synthes Radial Head Replacement System, Substantially Equivalent on 2022-03-18. Applicant: DePuy Synthes. Device class: 2.
Clearance details
- Applicant
- DePuy Synthes
- Product code
- Code KWI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3170
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Recent devices under product code KWI
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Adverse events under product code KWI
product code KWI- Injury
- 490
- Total
- 490
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.