Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K926107 |
Device Name |
ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS |
Applicant |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA S BERES |
Correspondent |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA S BERES |
Regulation Number | 888.3358
|
Classification Product Code |
|
Date Received | 12/03/1992 |
Decision Date | 07/28/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|