EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE— 510(k) K042772

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K042772 for EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE, Substantially Equivalent on 2004-12-13. Applicant: Ebi, L.P..

Clearance details

Applicant: Ebi, L.P.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2004-10-05
Decision date: 2004-12-13
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.