VU C*POD INTERVERTEBRAL BODY FUSION DEVICE— 510(k) K111675

Substantially Equivalent

Theken Spine, LLC

FDA 510(k) clearance K111675 for VU C*POD INTERVERTEBRAL BODY FUSION DEVICE, Substantially Equivalent on 2011-08-02. Applicant: Theken Spine, LLC.

Clearance details

Applicant: Theken Spine, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2011-06-15
Decision date: 2011-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Medina, OH, US

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.