VU APOD INTERVERTEBRAL BODY FUSION DEVICE— 510(k) K121211

Name: FDA 510(k) clearance K121211
Creator: U.S. Food and Drug Administration
Published: 2012-06-27

Substantially Equivalent

Theken Spine, LLC

FDA 510(k) clearance K121211 for VU APOD INTERVERTEBRAL BODY FUSION DEVICE, Substantially Equivalent on 2012-06-27. Applicant: Theken Spine, LLC. Device class: 2.

Clearance details

Applicant: Theken Spine, LLC
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2012-04-20
Decision date: 2012-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Medina, OH, US

Download summary PDF View on FDA.gov ↗

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K120047 — CORAL SPINAL SYSTEM2012-02-03
K111675 — VU C*POD INTERVERTEBRAL BODY FUSION DEVICE2011-08-02
K103228 — PARAMOUNT R IBF DEVICE2011-01-05

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.