FDA 510(k) Applications for Medical Device:
Cement, Bone, Vertebroplasty
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K090460 | AAP BIOMATERIALS GMBH |
LAGERSTRASSE 11-15 | DIEBURG | D-64807 | |
| K121876 | AAP BIOMATERIALS GMBH |
LAGERSTRASSE 11-15 | DIEBURG | D-64807 | |
| K110998 | ALGEA THERAPIES |
2560 GENERAL ARMISTEAD AVENUE | AUDUBON | PA | 19403 |
| K100404 | AOI MEDICAL, INC. |
1835 MARKET STREET | PHILADELPHIA | PA | 19103 |
| K110183 | ARTHROCARE CORP. |
680 VAQUEROS AVE. | SUNNYVALE | CA | 94085-3523 |
| K053180 | ARTHROCARE CORP. |
680 VAQUEROS AVE. | SUNNYVALE | CA | 94085-3523 |
| K060425 | ARTHROCARE CORP. |
680 VAQUEROS AVE. | SUNNYVALE | CA | 94085-3523 |
| K050864 | ARTHROCARE CORP. |
680 VAQUEROS AVE. | SUNNYVALE | CA | 94085-3523 |
| K042947 | ARTHROCARE CORP. |
680 VAQUEROS AVE. | SUNNYVALE | CA | 94085-3523 |
| K100479 | ARTHROCARE CORP. |
680 VAQUEROS AVE. | SUNNYVALE | CA | 94085-3523 |
| K113452 | ASCENDX SPINE, INC. |
1835 MARKET STREET, 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K132817 | BENVENUE MEDICAL, INC. |
1171 BARROILHET DR. | HILLSBOROUGH | CA | 94010 |
| K141141 | BENVENUE MEDICAL, INC. |
1171 BARROILHET DR. | HILLSBOROUGH | CA | 94010 |
| K111593 | BM KOREA CO., LTD. |
1733 CANTON LANE | MARIETTA | GA | 30062-2670 |
| K143006 | BM KOREA CO., LTD. |
325-26 DANGJEONG-DONG | GUNPO-SI | 435-832 | |
| K192403 | BONWRx Ltd |
924 Terminal Road | Lansing | MI | 48906 |
| K043518 | Cardinal Health |
1430 WAUKEGAN RD. | MCGAW PARK | IL | 60085 |
| K072133 | CARDINAL HEALTH, INC. |
1430 WAUKEGAN ROAD- MPKB-3B | MCGAW PARK | IL | 60085 |
| K090211 | CARDINAL HEALTH, INC. |
1430 WAUKEGAN ROAD- MPKB-3B | MCGAW PARK | IL | 60085 |
| K103064 | CAREFUSION |
1500 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K093463 | CAREFUSION |
1500 WAUKEGAN ROAD | WAUKEGAN | IL | 60085 |
| K042691 | COOK, INC. |
750 DANIELS WAY | BLOOMINGTON | IN | 47402 |
| K133372 | CROSSTREES MEDICAL, INC. |
135 MARKET ST., 29TH FLOOR | PHILADELPHIA | PA | 19119 |
| K130089 | CROSSTREES MEDICAL, INC. |
1835 MARKET ST., 28TH FLOOR | PHILADELPHIA | PA | 19103 |
| K071927 | DEPUY SPINE, A JOHNSON & JOHNSON COMPANY |
325 Paramount Drive | Raynham | MA | 02767 |
| K201831 | DePuy Spine, Inc. |
325 Paramount Drive | Raynham | MA | 02767-0350 |
| K043406 | DEPUY SPINE,INC |
325 PARAMONT DRIVE | RAYNHAM | MA | 02767 |
| K072496 | DFINE, INC. |
3047 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K070351 | DFINE, INC. |
19450 STEVENS CREEK BLVD. | CUPERTINO | CA | 95014 |
| K061531 | DFINE, INC. |
19450 STEVENS CREEK BLVD. | CUPERTINO | CA | 95014 |
| K090986 | DFINE, INC. |
3047 ORCHARD PKWY. | SAN JOSE | CA | 95134 |
| K062424 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K063067 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K060300 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
11 HA'HOSHLIM ST. | HERZLIYA | 46724 | |
| K071375 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K162283 | Dragon Crown Medical Co., Ltd. |
6F, Kehui Building, No. 109, Shunhua Road | Jinan | 250101 | |
| K060148 | EBI, L.P. |
399 JEFFERSON ROAD | PARSIPPANY | NJ | 07054 |
| K172214 | G-21 s.r.l. |
Via S. Pertini, 8 | San Possidonio | 41039 | |
| K152557 | G21 s.r.l. |
Via S. Pertini, 8 | San Possidonio | 41039 | |
| K042168 | Globus Medical, Inc |
2560 General Armistead Avenue | Audubon | PA | 19403 |
| K162618 | GLOBUS MEDICAL, INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K211797 | GS Medical Co. Ltd. |
90, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu | Cheongju-si | 28161 | |
| K192335 | GS Medical Co., Ltd. |
90, Osongsaengmyeong 4-ro | Osong-eup, Cheongwon-gun | 363-951 | |
| K172871 | Hanchang Co., Ltd. |
#301-204 Bucheon Techno-park | Bucheon-si | 14501 | |
| K191709 | Hyprevention SAS |
PTIB - Hopital Xavier Arnozan - Avenue du Haut-Leveque | PESSAC Cedex | 33604 | |
| K133669 | IMEDICOM |
2651 E CHAPMAN AVE STE 110 | FULLERTON | CA | 92833 |
| K153296 | IMEDICOM Co., Ltd. |
#612, 172, LS-ro | Gunpo-si | 435-824 | |
| K192449 | Joline GmbH & Co. KG |
Neue RottenBurger Strasse 50 | Hechingen | 72379 | |
| K041584 | KYPHON, INC. |
1221 CROSSMAN AVE. | SUNNYVALE | CA | 94089 |
| K033801 | KYPHON, INC. |
1350 BORDEAUX DR. | SUNNYVALE | CA | 94089 |
| K112907 | MEDOS INTERNATIONAL SARL |
325 Paramount Drive | Raynham | MA | 02767 |
| K102397 | Medtronic |
1221 CROSSMAN AVE. | SUNNYVALE | CA | 94089 |
| K151227 | MEDTRONIC |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K160983 | MEDTRONIC INC |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K093828 | MEDTRONIC INC. |
1221 CROSSMAN AVENUE | SUNNYVALE | CA | 94089 |
| K163032 | Medtronic Inc. |
1800 Pyramid Place | Memphis | TN | 38132 |
| K150460 | MEDTRONIC SOFAMOR DANCK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K063248 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K070527 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K180700 | Medtronic Sofamor Danek USA, Inc. |
1800 Pyramid Place | Memphis | TN | 38132 |
| K122503 | NEURO THERM, INC. |
200 Homer Ave | Ashland | MA | 01721 |
| K080108 | ORTHOVITA, INC. |
45 GREAT VALLEY PKWY. | MALVERN | PA | 19355 |
| K140937 | OSSEON LLC |
2330 CIRCADIAN WAY | SANTA ROSA | CA | 95407 |
| K150607 | OSSEON LLC |
2330 CIRCADIAN WAY | SANTA ROSA | CA | 95407 |
| K141930 | OSSEON LLC |
2330 CIRCADIAN WAY | SANTA ROSA | CA | 95407 |
| K122533 | OSSEON THERAPEUTICS, INC. |
2330 CIRCADIAN WAY | SANTA ROSA | CA | 95407 |
| K132620 | PAN MEDICAL LTD |
BARNETT WAY, BARNWOOD | GLOUCESTER, GLOUCESTERSHIRE | GL4 3RT | |
| K150322 | PAN MEDICAL LTD |
BARNETT WAY, BARNWOOD | GLOUCESTER | GL4 3RT | |
| K162453 | Pan Medical Ltd. |
Barnett Way, Barnwood | Gloucester | GL4 3RT | |
| K113742 | SHANGHAI KINETIC MEDICAL CO., LTD |
3924CASCADE BEACH ROAD | LUTSEN | MN | 55612 |
| K130402 | SINTEA PLUSTEK, LLC |
13540 GUILD AVE | APPLE VALLEY | MN | 55124 |
| K091234 | SKELTEX TECHNOLOGIES, INC. |
75 DE MORTAGNE BLVD. | BOUCHERVILLE, QUEBEC | J4B 6Y4 | |
| K221697 | SLK Ortho Llc |
5883 RFD | Long Grove | IL | 60047 |
| K093477 | SOTEIRA, INC. |
5 WHITCOMB AVENUE | AYER | MA | 01432 |
| K053336 | SPINE WAVE, INC. |
TWO ENTERPRISE DR. | SHELTON | CT | 06484 |
| K072118 | STRYKER CORP. |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K091606 | STRYKER CORP. |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K103807 | STRYKER CORPORATION |
4100 E. MILHAM AVE | KALAMAZOO | MI | 49001 |
| K113154 | STRYKER CORPORATION |
4100 E. MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K202393 | Stryker Corporation |
1926 Stryker Way | Kalamazoo | MI | 49002 |
| K123942 | STRYKER CORPORATION |
4100 E. MILHAM AVE | KALAMAZOO | MI | 49001 |
| K150582 | STRYKER CORPORATION |
4100 E. MILHAM AVENUE | KALAMAZOO | MI | 49001 |
| K211238 | Stryker Instruments |
1941 Stryker Way | Portage | MI | 49002 |
| K223294 | Stryker Instruments |
1941 Stryker Way | Portage | MI | 49002 |
| K093419 | STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K113477 | STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K110604 | SYNTHES |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K130146 | SYNTHES (USA) LLC |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K220131 | Tecres S.p.A. |
via Andrea Doria 6 | Sommacampagna | 37066 | |
| K062452 | TECRES SPA |
1700 RESEARCH BOULEVARD | ROCKVILLE | MD | 20850 |
| K042415 | TECRES SPA |
ONE DEMOCRACY PLAZA | BETHESDA | MD | 20817 |
| K122175 | TECRES SPA |
7 Trail House Court | Rockville | MD | 20850 |
| K063438 | TECRES SPA |
1700 RESEARCH BOULEVARD | ROCKVILLE | MD | 20850 |
| K103433 | TEKNIMED SA |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K080873 | TEKNIMED SA |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K043593 | TEKNIMED SA |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K090435 | TEKNIMED SA |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K103816 | TEKNIMED, S.A.S. |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K161114 | Teknimed, SAS |
11, Rue d'Apollo | L'Union | 31240 | |
| K181262 | Vexim SA |
8 Rue Vidailhan | Balma | 31130 | |
| K141419 | ZAVATION LLC |
400 LIBERTY PARK DR | FLOWOOD | MS | 39232 |
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