EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM— 510(k) K061978
Substantially EquivalentEbi, L.P.
FDA 510(k) clearance K061978 for EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM, Substantially Equivalent on 2006-08-11. Applicant: Ebi, L.P..
Clearance details
- Applicant
- Ebi, L.P.
- Product code
- Code MNI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Parsippany, NJ, US
Adverse events under product code MNI
product code MNI- Injury
- 641
- Total
- 641
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.