| 510(k) Number |
K860074 |
| Device Name |
SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS |
| Applicant |
| Warsaw Orthopedic, Inc. |
| 755 Crossover Ln. |
|
Memphis,
TN
38117
|
|
| Applicant Contact |
JAMES RITTER |
| Correspondent |
| Warsaw Orthopedic, Inc. |
| 755 Crossover Ln. |
|
Memphis,
TN
38117
|
|
| Correspondent Contact |
JAMES RITTER |
| Date Received | 01/07/1986 |
| Decision Date | 02/11/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|