Device Classification Name |
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
|
510(k) Number |
K050269 |
Device Name |
U1 HIP SYSTEM - BIPOLAR |
Applicant |
UNITED ORTHOPEDIC CORP. |
57 PARK AVE. 2, SCIENCE PARK |
HSINCHU,
TW
300
|
|
Applicant Contact |
GENE HUANG |
Correspondent |
UNITED ORTHOPEDIC CORP. |
57 PARK AVE. 2, SCIENCE PARK |
HSINCHU,
TW
300
|
|
Correspondent Contact |
GENE HUANG |
Regulation Number | 888.3390
|
Classification Product Code |
|
Date Received | 02/04/2005 |
Decision Date | 08/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|