Device Classification Name |
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
|
510(k) Number |
K101670 |
Device Name |
UNITED U2 BIPOLAR IMPLANT |
Applicant |
UNITED ORTHOPEDIC CORP. |
NO 57 PARK AVE. 2 |
SCIENCE PARK |
HSINCHU,
TW
300
|
|
Applicant Contact |
FANG-= YUAN HO |
Correspondent |
UNITED ORTHOPEDIC CORP. |
NO 57 PARK AVE. 2 |
SCIENCE PARK |
HSINCHU,
TW
300
|
|
Correspondent Contact |
FANG-= YUAN HO |
Regulation Number | 888.3390
|
Classification Product Code |
|
Date Received | 06/14/2010 |
Decision Date | 10/08/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|