FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CuffLink Implant System
K Number: K171725
·
Decision Sep 8, 2017
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
564
Applicant Total
14
Review Days
88
Basic Information
- Device Name
- CuffLink Implant System
- K Number
- K171725
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CONMED Corporation
- Date Received
- June 12, 2017
- Decision Date
- September 8, 2017
- 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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