Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
510(k) Number |
K152621 |
Device Name |
OSS/Arcos IM Total Femur Rod |
Applicant |
BIOMET, INC. |
56 EAST BELL DRIVE |
WARSAW,
IN
46581
|
|
Applicant Contact |
BRYAN MCMAHON |
Correspondent |
BIOMET, INC. |
56 EAST BELL DRIVE |
WARSAW,
IN
46581
|
|
Correspondent Contact |
BRYAN MCMAHON |
Regulation Number | 888.3350
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/14/2015 |
Decision Date | 10/14/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|