Chesapeake Stabilization System— 510(k) K142487

Name: FDA 510(k) clearance K142487
Creator: U.S. Food and Drug Administration
Published: 2015-05-07

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K142487 for Chesapeake Stabilization System, Substantially Equivalent on 2015-05-07. Applicant: K2m, Inc.. Device class: 2.

Clearance details

Applicant: K2m, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2014-09-04
Decision date: 2015-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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 →

Recalls naming K142487

K-number listed on FDA's recall record

Z-0104-2022 — Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068Class II·Terminated·K2M, Inc·20210908

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142487.

Data sourced from openFDA. This site is unofficial and independent of the FDA.