Consensus Orthopedics, Inc.
El Dorado Hills, CA, US
Consensus Orthopedics, Inc. appears in FDA device records in El Dorado Hills, CA. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Consensus Orthopedics, Inc. between 2010 and 2017. The busiest year on record is 2012, with 4. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170344 | Tahoe Uni Knee System | HSX | Substantially Equivalent | |
| K163167 | CKS Plus Knee System | JWH | Substantially Equivalent | |
| K160515 | PS2 Knee System | JWH | Substantially Equivalent | |
| K143725 | Consensus Knee System Modular Tibial Baseplate | JWH | Substantially Equivalent | |
| K133919 | CONSENSUS VITALITE TIBIAL INSERT | JWH | Substantially Equivalent | |
| K141043 | CS2 MULTI-HOLE ACETABULAR SHELL | LPH | Substantially Equivalent | |
| K130652 | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT | OQG | Substantially Equivalent | |
| K122512 | CS2 HIP SYSTEM | LPH | Substantially Equivalent | |
| K120595 | UNISYN PLUS HIP STEM | LWJ | Substantially Equivalent | |
| K121935 | TAPERSET HIP SMALL STEMS | LPH | Substantially Equivalent | |
| K121263 | TAPER SET HIP SYSTEM RDP STEM | LPH | Substantially Equivalent | |
| K110950 | CONSENSUS KNEE SYSTEM | MBH | Substantially Equivalent | |
| K110542 | CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD | LPH | Substantially Equivalent | |
| K102927 | CONSENSUS KNEE SYSTEM | MBH | Substantially Equivalent | |
| K102399 | CONSENSUS TAPERSET HIP SYSTEM | LPH | Substantially Equivalent | |
| K100933 | CONSENSUS CS2 PLUS ACETABULAR INSERT | LPH | Substantially Equivalent | |
| K100542 | CONSENSUS REVISION KNEE SYSTEM | JWH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain