Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K051411 |
FOIA Releasable 510(k) |
K051411
|
Device Name |
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
P.O. BOX 587 |
WARSAW,
IN
46582
|
|
Applicant Contact |
TRACY BICKEL JOHNSON |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
P.O. BOX 587 |
WARSAW,
IN
46582
|
|
Correspondent Contact |
TRACY BICKEL JOHNSON |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 05/31/2005 |
Decision Date | 06/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|