FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AxTiHA Stand-Alone ALIF System
K Number: K212967
·
Decision Oct 15, 2021
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
33
Review Days
29
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Basic Information
- Device Name
- AxTiHA Stand-Alone ALIF System
- K Number
- K212967
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovasis, Inc.
- Date Received
- September 16, 2021
- Decision Date
- October 15, 2021
- 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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