FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
FIX-C 3D Ti ACIF System
K Number: K243915
·
Decision Feb 18, 2025
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
53
Review Days
60
Basic Information
- Device Name
- FIX-C 3D Ti ACIF System
- K Number
- K243915
- 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
- December 20, 2024
- Decision Date
- February 18, 2025
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K243973 | FIX-L PEEK PLIF and T-PLIF System | Jun 12, 2025 | Substantially Equivalent |
| K242751 | ARIX Pectus Bar System | May 30, 2025 | Substantially Equivalent |
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| 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 |