PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM— 510(k) K930771
Substantially Equivalent for Some IndicationsOrthomet, Inc.
FDA 510(k) clearance K930771 for PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM, Substantially Equivalent for Some Indications on 1994-11-30. Applicant: Orthomet, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthomet, 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
- Minneapolis, MN, US
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More clearances from Orthomet, 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.