| Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
| 510(k) Number |
K871539 |
| Device Name |
ZINDRICK IM ROD |
| Applicant |
| BUCKMAN CO., INC. |
| 921 CALLE VERDE |
|
MARTINEZ,
CA
94553
|
|
| Applicant Contact |
DAVID W SCHLERF |
| Correspondent |
| BUCKMAN CO., INC. |
| 921 CALLE VERDE |
|
MARTINEZ,
CA
94553
|
|
| Correspondent Contact |
DAVID W SCHLERF |
| Regulation Number | 888.3020 |
| Classification Product Code |
|
| Date Received | 04/20/1987 |
| Decision Date | 08/17/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|