FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONQUEST FN
K Number: K172785
·
Decision Dec 22, 2017
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
22
Applicant Total
16
Review Days
98
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Basic Information
- Device Name
- CONQUEST FN
- K Number
- K172785
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew
- Date Received
- September 15, 2017
- Decision Date
- December 22, 2017
- Product Code
- JDO
- 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 |
|---|---|---|---|
| JDO | Device, Fixation, Proximal Femoral, Implant | FDA class 2 | Orthopedic |
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