Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K043547 |
FOIA Releasable 510(k) |
K043547
|
Device Name |
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
GARY BAKER |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
GARY BAKER |
Regulation Number | 888.3330
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/23/2004 |
Decision Date | 08/05/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|