FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
K Number: K130365
·
Decision Sep 23, 2013
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
19
Applicant Total
81
Review Days
222
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Basic Information
- Device Name
- X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
- K Number
- K130365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encore Medical L.P.
- Date Received
- February 13, 2013
- Decision Date
- September 23, 2013
- Product Code
- OQG
- 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 |
|---|---|---|---|
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | FDA class 2 | Orthopedic |
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