PROSTHETIC - FEMORAL HIP COMPONENT— 510(k) K871462
Substantially Equivalent for Some IndicationsLouis A. Serafin, Jr., M.D.
FDA 510(k) clearance K871462 for PROSTHETIC - FEMORAL HIP COMPONENT, Substantially Equivalent for Some Indications on 1987-06-04. Applicant: Louis A. Serafin, Jr., M.D.. Device class: 2.
Clearance details
- Applicant
- Louis A. Serafin, Jr., M.D.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Port Huron, MI, US
Recent devices under product code JDI
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- K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
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.