Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
510(k) Number |
K142295 |
Device Name |
Sirius Femoral Stem, Size 30A |
Applicant |
Biomet, Inc. |
56 East Bell Drive |
Warsaw,
IN
46581
|
|
Applicant Contact |
Jason Dugger |
Correspondent |
Biomet, Inc. |
56 East Bell Drive |
Warsaw,
IN
46581
|
|
Correspondent Contact |
Jason Dugger |
Regulation Number | 888.3350
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/18/2014 |
Decision Date | 09/15/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|