FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
CI../..X liner for NOVAE Dual Mobility Acetabular Cup
K Number: K142675
·
Decision Jan 15, 2015
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
4
Review Days
118
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Basic Information
- Device Name
- CI../..X liner for NOVAE Dual Mobility Acetabular Cup
- K Number
- K142675
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Serf
- Date Received
- September 19, 2014
- Decision Date
- January 15, 2015
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Serf
| K Number | Device Name | ||
|---|---|---|---|
| K223745 | Novae® Dual Mobility System, Hype® Hip System | Dec 22, 2023 | Substantially Equivalent |
| K181744 | BI-MENTUM dual mobility system | Dec 11, 2018 | Substantially Equivalent |
| K111572 | NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL | Aug 29, 2011 | Substantially Equivalent |