BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)— 510(k) K955927
Substantially Equivalent for Some IndicationsArcan Orthopaedic Corp.
FDA 510(k) clearance K955927 for BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION), Substantially Equivalent for Some Indications on 1996-03-13. Applicant: Arcan Orthopaedic Corp..
Clearance details
- Applicant
- Arcan Orthopaedic Corp.
- Product code
- Code KWP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Ogden, UT, US
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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.