Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
510(k) Number |
K002757 |
Device Name |
ONCOLOGY SALVAGE SYSTEM |
Applicant |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, |
P.O.BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
TINA LAKIN |
Correspondent |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, |
P.O.BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
TINA LAKIN |
Regulation Number | 888.3350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/05/2000 |
Decision Date | 11/24/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|