Device Classification Name |
hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
|
510(k) Number |
K172833 |
Device Name |
E-XPE Acetabular Components and U-Motion II Acetabular Cup |
Applicant |
United Orthopedic Corporation |
No 57, Park Ave 2, Science Park |
Hsinchu,
TW
300
|
|
Applicant Contact |
Gimpel Chien |
Correspondent |
United Orthopedic Corporation |
No 57, Park Ave 2, Science Park |
Hsinchu,
TW
300
|
|
Correspondent Contact |
Gimpel Chien |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/19/2017 |
Decision Date | 06/12/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|