Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K121263 |
Device Name |
TAPER SET HIP SYSTEM RDP STEM |
Applicant |
CONSENSUS ORTHOPEDICS, INC. |
1115 WINDFIELD WAY STE 100 |
EL DORADO HILLS,
CA
95762
|
|
Correspondent |
CONSENSUS ORTHOPEDICS, INC. |
1115 WINDFIELD WAY STE 100 |
EL DORADO HILLS,
CA
95762
|
|
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/26/2012 |
Decision Date | 05/22/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|