Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K062998 |
FOIA Releasable 510(k) |
K062998
|
Device Name |
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) |
Applicant |
BIOMET MANUFACTURING CORP. |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
JING XIE |
Correspondent |
BIOMET MANUFACTURING CORP. |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
JING XIE |
Regulation Number | 888.3330
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/02/2006 |
Decision Date | 01/19/2007 |
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
|