Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K011897 |
Device Name |
NORIAN SRS BONE VOID FILLER |
Applicant |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Applicant Contact |
ANGELA J SILVESTRI |
Correspondent |
SYNTHES (USA) |
1690 RUSSELL RD. |
PAOLI,
PA
19301
|
|
Correspondent Contact |
ANGELA J SILVESTRI |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 06/18/2001 |
Decision Date | 12/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|