PRIMALOC CEMENTED HIP SYSTEM— 510(k) K962448
Substantially Equivalent for Some IndicationsOrtho Development Corp.
FDA 510(k) clearance K962448 for PRIMALOC CEMENTED HIP SYSTEM, Substantially Equivalent for Some Indications on 1996-09-19. Applicant: Ortho Development Corp..
Clearance details
- Applicant
- Ortho Development Corp.
- Product code
- Code KWY
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Draper, UT, US
Adverse events under product code KWY
product code KWY- Death
- 3
- Injury
- 2,049
- Total
- 2,052
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.