| 510(k) Number |
K864337 |
| Device Name |
SEGMENTAL SPINAL INSTRUMENTATION SYSTEM |
| Applicant |
| Kirschner Medical Corp. |
| 9690 Deereco Rd.d |
|
Timonium,
MD
21093
|
|
| Applicant Contact |
SAM SON |
| Correspondent |
| Kirschner Medical Corp. |
| 9690 Deereco Rd.d |
|
Timonium,
MD
21093
|
|
| Correspondent Contact |
SAM SON |
| Date Received | 11/04/1986 |
| Decision Date | 12/16/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|