|
Device |
cement, bone, vertebroplasty |
Product Code | NDN |
Regulation Number |
888.3027
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AAP BIOMATERIALS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALGEA THERAPIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AOI MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHROCARE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ASCENDX SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BENVENUE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOPSYBELL S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BM KOREA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BONWRX LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDINAL HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CROSSTREES MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEPUY SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DFINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAGON CROWN MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
G-21 S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
G21 S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GS MEDICAL CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GS MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANCHANG CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HYPREVENTION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HYPREVENTION SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMEDICOM |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMEDICOM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JOLINE GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC SOFAMOR DANCK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEURO THERM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO HICREN BIOTECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOVITA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSEON LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OSSEON THERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAN MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PAN MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI KINETIC MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SINTEA PLUSTEK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKELTEX TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SLK ORTHO LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOTEIRA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
STRYKER INSTRUMENTS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES (USA) LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECRES S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECRES SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TEKNIMED SA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TEKNIMED, S.A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TEKNIMED, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VEXIM SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|