FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
FIX-C PEEK ACIF SA System
K Number: K251431
·
Decision Jun 27, 2025
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
53
Review Days
50
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
- FIX-C PEEK ACIF SA System
- K Number
- K251431
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jeil Medical Corporation
- Date Received
- May 8, 2025
- Decision Date
- June 27, 2025
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVE), ordered by most recent decision date.
CONDUIT ZERO-P VA Secured Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
NeckTune 3D SA Cervical Cage
FDA 510(k)
FDA Class 2
·Orthopedic
SABER-C System
FDA 510(k)
FDA Class 2
·Orthopedic
SAGI Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Uni-C Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
E3D-C Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Jeil Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252246 | Leforte MMF System | Apr 2, 2026 | Substantially Equivalent |
| K252826 | ARIX Femur Nail System | Dec 10, 2025 | Substantially Equivalent |
| K243973 | FIX-L PEEK PLIF and T-PLIF System | Jun 12, 2025 | Substantially Equivalent |
| K242751 | ARIX Pectus Bar System | May 30, 2025 | Substantially Equivalent |
| K242247 | ARIX Femur Nail System | Apr 22, 2025 | Substantially Equivalent |
| K243915 | FIX-C 3D Ti ACIF System | Feb 18, 2025 | Substantially Equivalent |
| K243004 | Xpine Spinal Fixation System | Nov 8, 2024 | Substantially Equivalent |
| K231251 | FlexWing Anterior Cervical Plate System | Jul 24, 2024 | Substantially Equivalent |
| K233912 | ARIX Cannulated Screw System | Mar 11, 2024 | Substantially Equivalent |
| K231887 | ARIX Ankle Distal Tibia System | Dec 14, 2023 | Substantially Equivalent |