| 510(k) Number |
K864788 |
| Device Name |
EXACTECH TOTAL HIP INSTRUMENTS |
| Applicant |
| Exactech, Inc. |
| 2210 NW 28th St. |
|
Gainesville,
FL
32605
|
|
| Applicant Contact |
WILLIAM PETTY |
| Correspondent |
| Exactech, Inc. |
| 2210 NW 28th St. |
|
Gainesville,
FL
32605
|
|
| Correspondent Contact |
WILLIAM PETTY |
| Date Received | 12/08/1986 |
| Decision Date | 12/29/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|