PHENIX VERTEBRAL BODY REPLACEMENT— 510(k) K072029

Substantially Equivalent

New Business Development, LLC

FDA 510(k) clearance K072029 for PHENIX VERTEBRAL BODY REPLACEMENT, Substantially Equivalent on 2007-10-15. Applicant: New Business Development, LLC.

Clearance details

Applicant: New Business Development, LLC
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2007-07-24
Decision date: 2007-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.