EBI P148 SPINAL FIXATION SYSTEM— 510(k) K031423

Name: FDA 510(k) clearance K031423
Creator: U.S. Food and Drug Administration
Published: 2003-06-27

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K031423 for EBI P148 SPINAL FIXATION SYSTEM, Substantially Equivalent on 2003-06-27. Applicant: Ebi, L.P.. Device class: 2.

Clearance details

Applicant: Ebi, L.P.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2003-05-06
Decision date: 2003-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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K100438 — POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM2010-06-23
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K092574 — ESL SPINAL SYSTEM2010-02-04
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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.