PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30— 510(k) K004003
Substantially EquivalentInterpore Cross Intl.
FDA 510(k) clearance K004003 for PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30, Substantially Equivalent on 2001-07-19. Applicant: Interpore Cross Intl..
Clearance details
- Applicant
- Interpore Cross Intl.
- Product code
- Code MQV
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
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.