HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY— 510(k) K852546
Substantially Equivalent for Some IndicationsHowmedica Corp.
FDA 510(k) clearance K852546 for HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY, Substantially Equivalent for Some Indications on 1985-08-21. Applicant: Howmedica Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Corp.
- 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
- Rutherford, NJ, US
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More clearances from Howmedica Corp.
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.