PERFECTA TOTAL HIP SYSTEM— 510(k) K880461
Substantially Equivalent for Some IndicationsOrthomet, Inc.
FDA 510(k) clearance K880461 for PERFECTA TOTAL HIP SYSTEM, Substantially Equivalent for Some Indications on 1988-03-15. 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.