FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VyPlate Anterior Cervical Plate System
K Number: K221572
·
Decision Jul 26, 2022
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
21
Review Days
55
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Basic Information
- Device Name
- VyPlate Anterior Cervical Plate System
- K Number
- K221572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vy Spine, LLC
- Date Received
- June 1, 2022
- Decision Date
- July 26, 2022
- Product Code
- KWQ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Vy Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K260697 | VyPlate Anterior Cervical Plate System | Mar 27, 2026 | Substantially Equivalent |
| K253432 | DiversiVy Facet Screw System | Mar 19, 2026 | Substantially Equivalent |
| K253158 | VyBrate VBR System | Jan 7, 2026 | Substantially Equivalent |
| K241783 | FortiVy OsteoVy Lumbar IBF | Mar 18, 2025 | Substantially Equivalent |
| K242784 | Vy Spine VyLam Laminoplasty System | Oct 16, 2024 | Substantially Equivalent |
| K233807 | LumiVy Lumbar IBF System | Sep 24, 2024 | Substantially Equivalent |
| K231836 | ClariVy Cervical IBF System | Oct 30, 2023 | Substantially Equivalent |
| K231744 | VyLink Spinal Screw System | Oct 13, 2023 | Substantially Equivalent |
| K232471 | Vy Spine VyLam Laminoplasty System | Oct 10, 2023 | Substantially Equivalent |
| K232167 | VySpan PCT System | Sep 27, 2023 | Substantially Equivalent |