ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)— 510(k) K950418
Substantially EquivalentWrightmedicaltechnologyinc
FDA 510(k) clearance K950418 for ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL), Substantially Equivalent on 1995-06-15. Applicant: Wrightmedicaltechnologyinc. Device class: 2.
Clearance details
- Applicant
- Wrightmedicaltechnologyinc
- 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
- Traditional
- Location
- Arlington, TN, US
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More clearances from Wrightmedicaltechnologyinc
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.