MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K002980

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K002980 for MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2000-10-23. Applicant: Ebi, L.P..

Clearance details

Applicant: Ebi, L.P.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2000-09-25
Decision date: 2000-10-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Parsippany, NJ, US

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.