Device Classification Name |
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
|
510(k) Number |
K091967 |
Device Name |
MEDACTA BIPOLAR HEAD |
Applicant |
MEDACTA INTERNATIONAL, SA |
13721 VIA TRES VISTA |
SAN DIEGO,
CA
92129
|
|
Applicant Contact |
NATALIE J KENNEL |
Correspondent |
MEDACTA INTERNATIONAL, SA |
13721 VIA TRES VISTA |
SAN DIEGO,
CA
92129
|
|
Correspondent Contact |
NATALIE J KENNEL |
Regulation Number | 888.3390
|
Classification Product Code |
|
Date Received | 07/01/2009 |
Decision Date | 03/02/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|