FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
UNiD IB3D ALIF
K Number: K200316
·
Decision Oct 30, 2020
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
25
Review Days
266
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
- UNiD IB3D ALIF
- K Number
- K200316
- 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 SA
- Date Received
- February 7, 2020
- Decision Date
- October 30, 2020
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAX), ordered by most recent decision date.
Fule Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Exceed® Biplanar Expandable Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
BMD Titanium Spinal Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Ventana® P/T Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
VersaLift Expandable System
FDA 510(k)
FDA Class 2
·Orthopedic
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Medicrea International SA
| K Number | Device Name | ||
|---|---|---|---|
| K213659 | LigaPASS 2.0 Ligament Augmentation System | May 24, 2022 | Substantially Equivalent |
| K213281 | PASS LP Spinal System, CD Horizon Spinal System | Jan 5, 2022 | Substantially Equivalent |
| K210470 | C-CURVE Interbody Fusion Device | Sep 3, 2021 | Substantially Equivalent |
| K191134 | IB3D ALIF | Oct 30, 2019 | Substantially Equivalent |
| K182158 | UNiD Patient-matched PLIF cage | Jul 15, 2019 | 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 |