EBI 5.5 HELICAL FLANGE SPINAL SYSTEM— 510(k) K061441

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K061441 for EBI 5.5 HELICAL FLANGE SPINAL SYSTEM, Substantially Equivalent on 2006-07-25. Applicant: Ebi, L.P..

Clearance details

Applicant: Ebi, L.P.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2006-05-24
Decision date: 2006-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.