FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Curiteva Porous PEEK Standalone ALIF System
K Number: K250845
·
Decision Jun 18, 2025
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
11
Review Days
90
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Basic Information
- Device Name
- Curiteva Porous PEEK Standalone ALIF System
- K Number
- K250845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Curiteva, Inc.
- Date Received
- March 20, 2025
- Decision Date
- June 18, 2025
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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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 |
| K243137 | Curiteva Porous PEEK Laminoplasty System | Oct 28, 2024 | 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 |