SPINAL PEDICLE SCREW, FIXATION, APPLIANCE— 510(k) K952298
Substantially Equivalent for Some IndicationsJ.B.S., S.A.
FDA 510(k) clearance K952298 for SPINAL PEDICLE SCREW, FIXATION, APPLIANCE, Substantially Equivalent for Some Indications on 1995-12-13. Applicant: J.B.S., S.A..
Clearance details
- Applicant
- J.B.S., S.A.
- Product code
- Code MNH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Foster City, CA, US
Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
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.