Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
510(k) Number |
K102927 |
Device Name |
CONSENSUS KNEE SYSTEM |
Applicant |
Consensus Orthopedics, Inc |
1115 WINFIELD WAY |
SUITE 100 |
EL DORADO HILLS,
CA
95762 -9623
|
|
Applicant Contact |
MATTHEW HULL |
Correspondent |
Consensus Orthopedics, Inc |
1115 WINFIELD WAY |
SUITE 100 |
EL DORADO HILLS,
CA
95762 -9623
|
|
Correspondent Contact |
MATTHEW HULL |
Regulation Number | 888.3565
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/04/2010 |
Decision Date | 01/26/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|