FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
K Number: K173583
·
Decision Mar 12, 2018
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
4
Applicant Total
186
Review Days
112
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Basic Information
- Device Name
- Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
- K Number
- K173583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- November 20, 2017
- Decision Date
- March 12, 2018
- Product Code
- OQI
- 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 |
|---|---|---|---|
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | FDA class 2 | Orthopedic |
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