EBI ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K001794

Name: FDA 510(k) clearance K001794
Creator: U.S. Food and Drug Administration
Published: 2000-07-12

Substantially Equivalent for Some Indications

Ebi, L.P.

FDA 510(k) clearance K001794 for EBI ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent for Some Indications on 2000-07-12. Applicant: Ebi, L.P.. Device class: 2.

Clearance details

Applicant: Ebi, L.P.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2000-06-14
Decision date: 2000-07-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Special
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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K092574 — ESL SPINAL SYSTEM2010-02-04
K093057 — BIOMET VISION FOOTRING SYSTEM2009-12-01

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.