VyPlate Anterior Cervical Plate System— 510(k) K260697
Substantially EquivalentVy 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.
Summary
Vy Spine's VyPlate Anterior Cervical Plate System is filed under KWQ, spinal intervertebral body fixation appliances. The record doesn't list plate sizes or components.
Class II, 21 CFR 888.3060. Orthopedic is both the classification panel and the review panel. It was a Special 510(k).
Vy Spine filed from Bountiful, Utah. The decision came 23 calendar days after receipt (March 4 to March 27, 2026).
Clearance details
- Applicant
- Vy Spine, LLC
- Product code
- Product code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bountiful, UT, US
Recent devices under product code KWQ
view allMore clearances from Vy Spine, LLC
view allAdverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
Source: openFDA MAUDE database, through . 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.