FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods
K Number: K222473
·
Decision Oct 13, 2022
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
1
Review Days
58
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Basic Information
- Device Name
- EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods
- K Number
- K222473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medos-International Sarl
- Date Received
- August 16, 2022
- Decision Date
- October 13, 2022
- 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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