| Device Classification Name |
prosthesis, hip, semi-constrained (metal cemented acetabular component)
|
| 510(K) Number |
K051348 |
| Device Name |
CONSERVE TOTAL FEMORAL HEAD |
| Applicant |
| WRIGHT MEDICAL TECHNOLOGY, INC. |
| 5677 airline rd. |
|
arlington,
TN
38002
|
|
| Contact |
theresa leister |
| Regulation Number | 888.3320
|
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 05/24/2005 |
| Decision Date | 08/19/2005 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Orthopedic
|
| Review Advisory Committee |
Orthopedic
|
| summary |
summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
| Combination Product |
No
|
|
|