EBI ESL PEEK-OPTIMA SPINE SYSTEM— 510(k) K061016

Name: FDA 510(k) clearance K061016
Creator: U.S. Food and Drug Administration
Published: 2006-06-08

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K061016 for EBI ESL PEEK-OPTIMA SPINE SYSTEM, Substantially Equivalent on 2006-06-08. Applicant: Ebi, L.P.. Device class: 2.

Clearance details

Applicant: Ebi, L.P.
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2006-04-13
Decision date: 2006-06-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.