Device Classification Name |
System, Facet Screw Spinal Device
|
510(k) Number |
K120340 |
Device Name |
VENUS FACET SCREW SYSTEM |
Applicant |
APOLLO SPINE, INC. |
75 MILL STREET |
STOUGHTON,
MA
02072
|
|
Applicant Contact |
CHRISTINE SANTAGATE |
Correspondent |
APOLLO SPINE, INC. |
75 MILL STREET |
STOUGHTON,
MA
02072
|
|
Correspondent Contact |
CHRISTINE SANTAGATE |
Classification Product Code |
|
Date Received | 02/03/2012 |
Decision Date | 10/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|