Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K082996 |
FOIA Releasable 510(k) |
K082996
|
Device Name |
BIOLOX DELTA OPTION CERAMIC HEADS |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA SANDBORN BERES |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA SANDBORN BERES |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 10/08/2008 |
Decision Date | 01/15/2009 |
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
|
|
|