FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
R3 XLPE LINERS
K Number: K113848
·
Decision Apr 27, 2012
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
12
Applicant Total
529
Review Days
120
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Basic Information
- Device Name
- R3 XLPE LINERS
- K Number
- K113848
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- December 29, 2011
- Decision Date
- April 27, 2012
- Product Code
- MBL
- 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 |
|---|---|---|---|
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | FDA class 2 | Orthopedic |
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