VyPlate Anterior Cervical Plate System— 510(k) K260697

Name: FDA 510(k) clearance K260697
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Substantially Equivalent

Vy Spine, LLC

FDA 510(k) clearance K260697 for VyPlate Anterior Cervical Plate System, Substantially Equivalent on 2026-03-27. Applicant: Vy Spine, LLC. Device class: 2.

Clearance details

Applicant: Vy Spine, LLC
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2026-03-04
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Bountiful, UT, 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
K260015 — ANTERIS Thoracolumbar Plate System2026-03-04

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K253432 — DiversiVy Facet Screw System2026-03-19
K253158 — VyBrate VBR System2026-01-07
K241783 — FortiVy OsteoVy Lumbar IBF2025-03-18
K242784 — Vy Spine VyLam Laminoplasty System2024-10-16
K233807 — LumiVy Lumbar IBF System2024-09-24

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.