Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K103733 |
Device Name |
UNITED U2 XPE TOTAL KNEE SYSTEM |
Applicant |
UNITED ORTHOPEDIC CORPORATION |
NO 57, PARK AVE 2, |
SCIENCE PARK |
HSINCHU,
TW
300
|
|
Applicant Contact |
FANG-YUAN HO |
Correspondent |
UNITED ORTHOPEDIC CORPORATION |
NO 57, PARK AVE 2, |
SCIENCE PARK |
HSINCHU,
TW
300
|
|
Correspondent Contact |
FANG-YUAN HO |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 12/22/2010 |
Decision Date | 08/02/2011 |
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
|
|
|