FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NILE Alternative Fixation Spinal System
K Number: K160208
·
Decision Mar 18, 2016
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
36
Applicant Total
100
Review Days
50
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Basic Information
- Device Name
- NILE Alternative Fixation Spinal System
- K Number
- K160208
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m, Inc.
- Date Received
- January 28, 2016
- Decision Date
- March 18, 2016
- Product Code
- OWI
- 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 |
|---|---|---|---|
| OWI | Bone Fixation Cerclage, Sublaminar | FDA class 2 | Orthopedic |
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