FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Caspian OCT/MESA Mini/DENALI Mini Spinal System
K Number: K142558
·
Decision Dec 22, 2014
Classifications
1
FEI Numbers
330
Registration Numbers
330
Same Product Code
429
Applicant Total
16
Review Days
102
Basic Information
- Device Name
- Caspian OCT/MESA Mini/DENALI Mini Spinal System
- K Number
- K142558
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2M
- Date Received
- September 11, 2014
- Decision Date
- December 22, 2014
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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