FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
K Number: K173499
·
Decision Mar 19, 2018
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
58
Applicant Total
24
Review Days
126
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Basic Information
- Device Name
- Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
- K Number
- K173499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Orthopaedics
- Date Received
- November 13, 2017
- Decision Date
- March 19, 2018
- Product Code
- JDG
- 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 |
|---|---|---|---|
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | FDA class 2 | Orthopedic |
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