PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP— 510(k) K911802
Substantially Equivalent for Some IndicationsBiomet, Inc.
FDA 510(k) clearance K911802 for PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP, Substantially Equivalent for Some Indications on 1992-01-02. Applicant: Biomet, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet, Inc.
- 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
- Warsaw, IN, US
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More clearances from Biomet, Inc.
view allAdverse 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.