EBI SPINELINK SPINAL FIXATION SYSTEM— 510(k) K031424

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K031424 for EBI SPINELINK SPINAL FIXATION SYSTEM, Substantially Equivalent on 2003-07-22. Applicant: Ebi, L.P..

Clearance details

Applicant: Ebi, L.P.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2003-05-06
Decision date: 2003-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.