EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM— 510(k) K973923
Substantially Equivalent for Some IndicationsEbi Electro Biology
FDA 510(k) clearance K973923 for EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM, Substantially Equivalent for Some Indications on 1998-01-13. Applicant: Ebi Electro Biology.
Clearance details
- Applicant
- Ebi Electro Biology
- Product code
- Code KWQ
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.