RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM— 510(k) K023085
Substantially EquivalentBiomet Orthopedics, Inc.
FDA 510(k) clearance K023085 for RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM, Substantially Equivalent on 2002-10-17. Applicant: Biomet Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet Orthopedics, Inc.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
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More clearances from Biomet Orthopedics, 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.