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

Name: FDA 510(k) clearance K152987
Creator: U.S. Food and Drug Administration
Published: 2015-12-11

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. Device class: 2.

Clearance details

Applicant: Xenco Medical, LLC
Product code: Product code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

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K254130 — C.A. Medical Interbody Fusion System2026-07-08

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K191074 — Sorrento Bone Graft Substitute2019-09-27
K190364 — CancelleX Porous Titanium Lumbar Interbody Device2019-04-18

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.