FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEURO VENTION LAMINPLASTY PLATING SYSTEM
K Number: K121276
·
Decision Aug 29, 2012
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
29
Applicant Total
2
Review Days
124
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Basic Information
- Device Name
- NEURO VENTION LAMINPLASTY PLATING SYSTEM
- K Number
- K121276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurovention, LLC
- Date Received
- April 27, 2012
- Decision Date
- August 29, 2012
- Product Code
- NQW
- 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 |
|---|---|---|---|
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | FDA class 2 | Orthopedic |
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Other Clearances by Neurovention, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | Mar 13, 2020 | Substantially Equivalent |