FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ArtFX Spinal Fixation System
K Number: K212220
·
Decision Apr 20, 2023
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
2
Review Days
643
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Basic Information
- Device Name
- ArtFX Spinal Fixation System
- K Number
- K212220
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Artfx Medical, LLC
- Date Received
- July 16, 2021
- Decision Date
- April 20, 2023
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NKB), ordered by most recent decision date.
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PERLA® TL Posterior Thoraco-lumbar Fixation System
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Other Clearances by Artfx Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K211718 | Venus Cervical Plate System | Jun 28, 2022 | Substantially Equivalent |