FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Axis Spine Technologies ALIF
K Number: K200352
·
Decision May 20, 2020
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
2
Review Days
97
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Basic Information
- Device Name
- Axis Spine Technologies ALIF
- K Number
- K200352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axis Spine Technologies, Ltd.
- Date Received
- February 13, 2020
- Decision Date
- May 20, 2020
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Axis Spine Technologies, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K210590 | Axis Spine Technologies ALIF | Sep 29, 2021 | Substantially Equivalent |