Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System— 510(k) K223719

Name: FDA 510(k) clearance K223719
Creator: U.S. Food and Drug Administration
Published: 2023-01-11

Substantially Equivalent

Aegis Spine, Inc.

FDA 510(k) clearance K223719 for Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System, Substantially Equivalent on 2023-01-11. Applicant: Aegis Spine, Inc.. Device class: 2.

Clearance details

Applicant: Aegis Spine, Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2022-12-12
Decision date: 2023-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

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K261309 — Palisades Buttress Plate System2026-07-16
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

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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.