ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ— 510(k) K023994

Name: FDA 510(k) clearance K023994
Creator: U.S. Food and Drug Administration
Published: 2003-02-05

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K023994 for ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ, Substantially Equivalent on 2003-02-05. Applicant: Ortho Tec, LLC. Device class: 2.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2002-12-03
Decision date: 2003-02-05
Decision: Substantially Equivalent
Clearance type: Special
Location: California, CA, US

Download summary PDF View on FDA.gov ↗

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K040514 — EOVIA CALCIUM PHOSPHATE CERAMIC2004-05-03
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K030958 — ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS2003-11-20
K031471 — ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL012003-10-10
K023884 — MODIFICATION ORIA SPINAL SYSTEM2003-08-20

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.