Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow— 510(k) K181307
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K181307 for Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow, Substantially Equivalent on 2019-01-28. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code JDC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3150
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
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Adverse events under product code JDC
product code JDC- Injury
- 1,050
- Total
- 1,050
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.