| 510(k) Number |
K870099 |
| Device Name |
PIVOTING SURGICAL ARM BOARDS |
| Applicant |
| Orthopedic Systems, Inc. |
| 1897 National Ave. |
|
Hayward,
CA
94545
|
|
| Applicant Contact |
ROBERT R MOORE |
| Correspondent |
| Orthopedic Systems, Inc. |
| 1897 National Ave. |
|
Hayward,
CA
94545
|
|
| Correspondent Contact |
ROBERT R MOORE |
| Date Received | 01/09/1987 |
| Decision Date | 02/06/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|