Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K093549 |
FOIA Releasable 510(k) |
K093549
|
Device Name |
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM |
Applicant |
BIOMET MANUFACTURING CORP. |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
BECKY EARL |
Correspondent |
BIOMET MANUFACTURING CORP. |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
BECKY EARL |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/17/2009 |
Decision Date | 12/16/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|