FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AERO MIS Facet Fusion System
K Number: K243865
·
Decision Mar 24, 2025
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
3
Review Days
97
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Basic Information
- Device Name
- AERO MIS Facet Fusion System
- K Number
- K243865
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aurora Spine
- Date Received
- December 17, 2024
- Decision Date
- March 24, 2025
- Product Code
- MRW
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
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