FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
K Number: K253577
·
Decision Dec 19, 2025
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
4
Review Days
32
Basic Information
- Device Name
- IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
- K Number
- K253577
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicrea International S.A.S. (Medtronic)
- Date Received
- November 17, 2025
- Decision Date
- December 19, 2025
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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