| Device Classification Name |
Prosthesis, Hip, Femoral Component, Cemented, Metal
|
| 510(k) Number |
K933871 |
| Device Name |
BRIDGE(TM) HIP SYSTEM |
| Applicant |
| Wrightmedicaltechnologyinc |
| 5677 Airline Rd. |
|
Arlington,
TN
38002
|
|
| Applicant Contact |
JUDY ENGLISH |
| Correspondent |
| Wrightmedicaltechnologyinc |
| 5677 Airline Rd. |
|
Arlington,
TN
38002
|
|
| Correspondent Contact |
JUDY ENGLISH |
| Regulation Number | 888.3360 |
| Classification Product Code |
|
| Date Received | 08/09/1993 |
| Decision Date | 02/23/1994 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|