EXPEDIUM SPINE SYSTEM— 510(k) K102249
Substantially EquivalentDepuy Spine, A Johnson & Johnson Company
FDA 510(k) clearance K102249 for EXPEDIUM SPINE SYSTEM, Substantially Equivalent on 2010-12-16. Applicant: Depuy Spine, A Johnson & Johnson Company.
Clearance details
- Applicant
- Depuy Spine, A Johnson & Johnson Company
- Product code
- Code NKB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Raynham, MA, 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.