Device Classification Name |
Orthosis, Spinal Pedicle Fixation
|
510(k) Number |
K990059 |
Device Name |
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS |
Applicant |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
KATE SUTTON |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
KATE SUTTON |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/08/1999 |
Decision Date | 01/28/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|