FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
K Number: K122822
·
Decision Feb 7, 2013
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
29
Applicant Total
4
Review Days
146
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Basic Information
- Device Name
- SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
- K Number
- K122822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrum Spine, LLC
- Date Received
- September 14, 2012
- Decision Date
- February 7, 2013
- 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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