Xenco Medical Posterior Cervical System— 510(k) K161478

Clearance details

Applicant

Xenco Medical, LLC

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2016-05-31

Decision date

2016-09-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Diego, CA, US

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

Death

15

Injury

1,090

Malfunction

529

Total

1,634

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 →