FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
V-STEADY, V-FAST
K Number: K150408
·
Decision Dec 14, 2015
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
71
Applicant Total
12
Review Days
299
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Basic Information
- Device Name
- V-STEADY, V-FAST
- K Number
- K150408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- G21, S.R.L.
- Date Received
- February 18, 2015
- Decision Date
- December 14, 2015
- Product Code
- LOD
- 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 |
|---|---|---|---|
| LOD | Bone Cement | FDA class 2 | Orthopedic |
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