Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K973868 |
Device Name |
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) |
Applicant |
OSTEOTECH, INC. |
51 JAMES WAY |
EATONTOWN,
NJ
07724
|
|
Applicant Contact |
CHRISTOPHER TALBOT |
Correspondent |
OSTEOTECH, INC. |
51 JAMES WAY |
EATONTOWN,
NJ
07724
|
|
Correspondent Contact |
CHRISTOPHER TALBOT |
Regulation Number | 888.3050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/10/1997 |
Decision Date | 01/08/1998 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|