Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
|
510(k) Number |
K004043 |
Device Name |
METAL TRANSCEND ARTICULATION SYSTEM |
Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Applicant Contact |
EHAB M ESMAIL |
Correspondent |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Correspondent Contact |
EHAB M ESMAIL |
Regulation Number | 888.3320
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/29/2000 |
Decision Date | 07/13/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|