Device Classification Name |
bone cement, antibiotic
|
510(k) Number |
K150850 |
FOIA Releasable 510(k) |
K150850
|
Device Name |
Refobacin Bone Cement R |
Applicant |
BIOMET, INC. |
56 EAST BELL DRIVE |
warsaw,
IN
46581
|
|
Applicant Contact |
carmen albany |
Correspondent |
BIOMET, INC. |
56 EAST BELL DRIVE |
warsaw,
IN
46581
|
|
Correspondent Contact |
carmen albany |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/31/2015 |
Decision Date | 07/16/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|