Axis Chena Cervical PEEK Spacer System— 510(k) K181140

Name: FDA 510(k) clearance K181140
Creator: U.S. Food and Drug Administration
Published: 2018-11-16

Substantially Equivalent

Axis Orthopaedics

FDA 510(k) clearance K181140 for Axis Chena Cervical PEEK Spacer System, Substantially Equivalent on 2018-11-16. Applicant: Axis Orthopaedics. Device class: 2.

Clearance details

Applicant: Axis Orthopaedics
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2018-04-30
Decision date: 2018-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Soldotna, AK, US

Download summary PDF View on FDA.gov ↗

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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.