FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
K Number: K180822
·
Decision Jan 28, 2019
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
6
Review Days
304
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Basic Information
- Device Name
- VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
- K Number
- K180822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wenzel Spine, Inc.
- Date Received
- March 30, 2018
- Decision Date
- January 28, 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 Wenzel Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250247 | panaSIa SI Fusion System | Jul 9, 2025 | Substantially Equivalent |
| K231076 | VariLift®-C Interbody Fusion System | Sep 27, 2023 | Substantially Equivalent |
| K231807 | primaLOK SP Interspinous Fusion System | Aug 15, 2023 | Substantially Equivalent |
| K151900 | VariLift-L Interbody Fusion Device | Dec 11, 2015 | Substantially Equivalent |
| K131296 | VARILIFT-L INTERBODY FUSION DEVICE | Sep 3, 2013 | Substantially Equivalent |