FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
IB3D ALIF
K Number: K191134
·
Decision Oct 30, 2019
Classifications
1
FEI Numbers
422
Registration Numbers
422
Same Product Code
869
Applicant Total
8
Review Days
184
Basic Information
- Device Name
- IB3D ALIF
- K Number
- K191134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicrea International S.A.
- Date Received
- April 29, 2019
- Decision Date
- October 30, 2019
- 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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Other Clearances by Medicrea International S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K200316 | UNiD IB3D ALIF | Oct 30, 2020 | Substantially Equivalent |
| K190092 | UNiD Patient specific 3D printed TLIF cage | May 8, 2019 | Substantially Equivalent |
| K190376 | PASS LP Spinal System | May 2, 2019 | Substantially Equivalent |
| K182240 | PASS LP Spinal System | Oct 17, 2018 | Substantially Equivalent |
| K173782 | UNiD Patient Specific 3D printed cage | Apr 25, 2018 | Substantially Equivalent |
| K173506 | LigaPASS | Apr 3, 2018 | Substantially Equivalent |
| K172021 | LigaPASS | Aug 30, 2017 | Substantially Equivalent |