CONQUEST SPINAL SYSTEM— 510(k) K090320
Substantially EquivalentLife Spine
FDA 510(k) clearance K090320 for CONQUEST SPINAL SYSTEM, Substantially Equivalent on 2009-07-22. Applicant: Life Spine.
Clearance details
- Applicant
- Life Spine
- Product code
- Code NKB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hoffman Estates, IL, US
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.