Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K003237 |
Device Name |
U2 HIP STEM, TI POROUS COATED |
Applicant |
UNITED ORTHOPEDIC CORP. |
57 PARK AVE. 2, SCIENCE PARK |
HSINCHU,
TW
300
|
|
Applicant Contact |
MELLEN LIU |
Correspondent |
UNITED ORTHOPEDIC CORP. |
57 PARK AVE. 2, SCIENCE PARK |
HSINCHU,
TW
300
|
|
Correspondent Contact |
MELLEN LIU |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/17/2000 |
Decision Date | 01/10/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|