FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elite SPK, Compasso, Elite SPK Kit
K Number: K160500
·
Decision Apr 20, 2016
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
4
Review Days
57
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Basic Information
- Device Name
- Elite SPK, Compasso, Elite SPK Kit
- K Number
- K160500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ncs Lab Srl
- Date Received
- February 23, 2016
- Decision Date
- April 20, 2016
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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