PHENIX CERVICAL INTERBODY DEVICE— 510(k) K083167

Substantially Equivalent

Spinal Devices, LLC

FDA 510(k) clearance K083167 for PHENIX CERVICAL INTERBODY DEVICE, Substantially Equivalent on 2009-01-13. Applicant: Spinal Devices, LLC.

Clearance details

Applicant: Spinal Devices, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2008-10-27
Decision date: 2009-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apple Valley, MN, US

Download summary PDF View on FDA.gov ↗

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.