Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System— 510(k) K152987

Substantially Equivalent

Xenco Medical, LLC

FDA 510(k) clearance K152987 for Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System, Substantially Equivalent on 2015-12-11. Applicant: Xenco Medical, LLC.

Clearance details

Applicant: Xenco Medical, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2015-10-13
Decision date: 2015-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.