FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARAI Surgical Navigation System
K Number: K211254
·
Decision Jan 14, 2022
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
41
Applicant Total
3
Review Days
263
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Basic Information
- Device Name
- ARAI Surgical Navigation System
- K Number
- K211254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgalign Spine Technologies
- Date Received
- April 26, 2021
- Decision Date
- January 14, 2022
- Product Code
- SBF
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| SBF | Orthopedic Augmented Reality | FDA class 2 | Neurology |
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