ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS— 510(k) K924115
Substantially EquivalentJohnson & Johnson Orthopaedics, Inc.
FDA 510(k) clearance K924115 for ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS, Substantially Equivalent on 1992-11-24. Applicant: Johnson & Johnson Orthopaedics, Inc..
Clearance details
- Applicant
- Johnson & Johnson Orthopaedics, Inc.
- Product code
- Code JDI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raynham, MA, US
Adverse events under product code JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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.