FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
K Number: K130652
·
Decision Dec 17, 2013
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
19
Applicant Total
17
Review Days
280
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Basic Information
- Device Name
- VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
- K Number
- K130652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Consensus Orthopedics, Inc.
- Date Received
- March 12, 2013
- Decision Date
- December 17, 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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Other Clearances by Consensus Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K170344 | Tahoe Uni Knee System | Oct 5, 2017 | Substantially Equivalent |
| K163167 | CKS Plus Knee System | Aug 9, 2017 | Substantially Equivalent |
| K160515 | PS2 Knee System | Dec 19, 2016 | Substantially Equivalent |
| K143725 | Consensus Knee System Modular Tibial Baseplate | Mar 4, 2015 | Substantially Equivalent |
| K133919 | CONSENSUS VITALITE TIBIAL INSERT | Jul 14, 2014 | Substantially Equivalent |
| K141043 | CS2 MULTI-HOLE ACETABULAR SHELL | May 19, 2014 | Substantially Equivalent |
| K122512 | CS2 HIP SYSTEM | Nov 5, 2012 | Substantially Equivalent |
| K120595 | UNISYN PLUS HIP STEM | Oct 12, 2012 | Substantially Equivalent |
| K121935 | TAPERSET HIP SMALL STEMS | Sep 10, 2012 | Substantially Equivalent |
| K121263 | TAPER SET HIP SYSTEM RDP STEM | May 22, 2012 | Substantially Equivalent |