THEKEN ATOLL OCT SPINAL SYSTEM— 510(k) K083863

Name: FDA 510(k) clearance K083863
Creator: U.S. Food and Drug Administration
Published: 2009-03-27

Substantially Equivalent

Theken Spine, LLC

FDA 510(k) clearance K083863 for THEKEN ATOLL OCT SPINAL SYSTEM, Substantially Equivalent on 2009-03-27. Applicant: Theken Spine, LLC. Device class: 2.

Clearance details

Applicant: Theken Spine, LLC
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2008-12-29
Decision date: 2009-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.