Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K954417 |
Device Name |
A-B ACETABULAR COMPONENT |
Applicant |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581
|
|
Applicant Contact |
PATRICIA S BERES |
Correspondent |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581
|
|
Correspondent Contact |
PATRICIA S BERES |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/21/1995 |
Decision Date | 12/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|