Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
|
510(k) Number |
K062693 |
Device Name |
GLADIATOR BIPOLAR SYSTEM |
Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Applicant Contact |
MATT PAUL |
Correspondent |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Correspondent Contact |
MATT PAUL |
Regulation Number | 888.3390
|
Classification Product Code |
|
Date Received | 09/11/2006 |
Decision Date | 09/29/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|