Cascadia Interbody System— 510(k) K160125

Name: FDA 510(k) clearance K160125
Creator: U.S. Food and Drug Administration
Published: 2016-04-22

Substantially Equivalent

K2m

FDA 510(k) clearance K160125 for Cascadia Interbody System, Substantially Equivalent on 2016-04-22. Applicant: K2m. Device class: 2.

Clearance details

Applicant: K2m
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2016-01-20
Decision date: 2016-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

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K182182 — YUKON OCT Spinal System2018-11-15
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K171556 — K2M Navigation Instruments2018-01-16
K173508 — Everest Spinal System2018-01-09

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.