FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Curiteva Porous PEEK Laminoplasty System
K Number: K243137
·
Decision Oct 28, 2024
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
29
Applicant Total
11
Review Days
28
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Curiteva Porous PEEK Laminoplasty System
- K Number
- K243137
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Curiteva, Inc.
- Date Received
- September 30, 2024
- Decision Date
- October 28, 2024
- Product Code
- NQW
- 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 |
|---|---|---|---|
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQW), ordered by most recent decision date.
AQUA Laminoplasty Systems
FDA 510(k)
FDA Class 2
·Orthopedic
Vy Spine VyLam Laminoplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Vy Spine VyLam Laminoplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Curiteva Laminoplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Centerpiece Plate Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Hinged Laminoplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Curiteva, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Jan 16, 2026 | Substantially Equivalent |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Jan 15, 2026 | Substantially Equivalent |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Jun 18, 2025 | Substantially Equivalent |
| K233360 | Curiteva Thoracolumbar Plate System | Feb 29, 2024 | Substantially Equivalent |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | Jan 18, 2024 | Substantially Equivalent |
| K231232 | Curiteva Laminoplasty System | Jun 28, 2023 | Substantially Equivalent |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Feb 13, 2023 | Substantially Equivalent |
| K223200 | Curiteva Navigation System | Jan 6, 2023 | Substantially Equivalent |
| K210402 | Curiteva Sacroiliac Joint Fusion System | Sep 9, 2021 | Substantially Equivalent |
| K191810 | Curiteva Pedicle Screw System | Aug 28, 2019 | Substantially Equivalent |