FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Solanas® Posterior Stabilization System
K Number: K173522
·
Decision Nov 30, 2017
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
4
Review Days
16
Basic Information
- Device Name
- Solanas® Posterior Stabilization System
- K Number
- K173522
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alphatec Spine, Inc
- Date Received
- November 14, 2017
- Decision Date
- November 30, 2017
- 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 |
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