FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVEREST SPINAL SYSTEM
K Number: K120656
·
Decision Apr 4, 2012
Classifications
1
FEI Numbers
354
Registration Numbers
354
Same Product Code
302
Applicant Total
64
Review Days
30
Basic Information
- Device Name
- EVEREST SPINAL SYSTEM
- K Number
- K120656
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2M, INC.
- Date Received
- March 5, 2012
- Decision Date
- April 4, 2012
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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