MOUNTAINEER OCT SPINAL SYSTEM— 510(k) K080828

Name: FDA 510(k) clearance K080828
Creator: U.S. Food and Drug Administration
Published: 2008-06-27

Substantially Equivalent

Depuy Spine, Inc.

FDA 510(k) clearance K080828 for MOUNTAINEER OCT SPINAL SYSTEM, Substantially Equivalent on 2008-06-27. Applicant: Depuy Spine, Inc.. Device class: 2.

Clearance details

Applicant: Depuy Spine, Inc.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2008-03-25
Decision date: 2008-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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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.