KING COBRA ANTERIOR CERVICAL PLATE— 510(k) K103068

Name: FDA 510(k) clearance K103068
Creator: U.S. Food and Drug Administration
Published: 2011-01-14

Substantially Equivalent

Eminent Spine

FDA 510(k) clearance K103068 for KING COBRA ANTERIOR CERVICAL PLATE, Substantially Equivalent on 2011-01-14. Applicant: Eminent Spine. Device class: 2.

Clearance details

Applicant: Eminent Spine
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2010-10-18
Decision date: 2011-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterland, OH, US

Download summary PDF View on FDA.gov ↗

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K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

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K212701 — Eminent Spine 3D Cervical Interbody Fusion System2023-02-06
K221936 — Standalone ALIF Interbody Fusion System2022-10-17

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.