FDA 510(k) Applications for Medical Device:
Prosthesis, Hip, Cement Restrictor
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K050699 | AMEDICA CORP. |
615 ARAPEEN DRIVE | SALT LAKE CITY | UT | 84108 |
| K022615 | CENTERPULSE SPINE-TECH, INC. |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55439-3037 |
| K021765 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K033384 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K041583 | INNOVASIS, INC. |
997 EAST 3900 SOUTH | SALT LAKE CITY | UT | 84124 |
| K051371 | INTERBODY INNOVATIONS LLP |
2454 MCMULLEN BOOTH RD. | CLEARWATER | FL | 33759 |
| K023908 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K032095 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K061465 | KINETIKOS MEDICAL, INC. |
6005 HIDDEN VALLEY RD, STE 180 | CARLSBAD | CA | 92011 |
| K060247 | LIFE SPINE |
2400 HASSELL ROAD | HOFFMAN ESTATES | IL | 60195 |
| K061698 | LIFE SPINE |
2400 HASSELL ROAD | HOFFMAN ESTATES | IL | 60195 |
| K210062 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K011443 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K010528 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K013014 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K013663 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K012255 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K011998 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K003718 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K051836 | MILLENIUM BIOLOGIX, INC. |
1129 BLOOMFIELD AVE. | WEST CALDWELL | NJ | 07006 |
| K021788 | NEW BUSINESS DEVELOPMENT, LLC |
605 INDUSTRIAL COURT | WOODSTOCK | GA | 30189 |
| K051607 | NOVASPINE LLC |
PO BOX 969 | ELMSFORD | NY | 10523 |
| K032180 | NUVASIVE, INC. |
10065 OLD GROVE RD. | SAN DIEGO | CA | 92131 |
| K041382 | OSTEOBIOLOGICS, INC. |
12500 NETWORK | SAN ANTONIO | TX | 78249 |
| K030608 | OSTEOIMPLANT TECHNOLOGY, INC. |
11201 PEPPER RD. | HUNT VALLEY | MD | 21031-1201 |
| K965056 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K040276 | QUANTUM ORTHOPEDICS |
11662 CORTE GUERA | SAN DIEGO | CA | 92128 |
| K052367 | SCIENT'X |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681 |
| K020836 | SIGNUS MEDICAL LLC. |
4050 OLSON MEMORIAL HIGHWAY | MINNEAPOLIS | MN | 55422 |
| K990345 | SIGNUS MEDIZINTECHNIK GMBH |
27660 WOODSIDE RD. | SHOREWOOD | MN | 55331 |
| K022218 | SPINAL CONCEPTS, INC. |
12012 TECHNOLOGY BLVD., #100 | AUSTIN | TX | 78727 |
| K023647 | SPINAL CONCEPTS, INC. |
12012 TECHNOLOGY BLVD., #100 | AUSTIN | TX | 78727 |
| K021719 | SPINAL CONCEPTS, INC. |
12012 TECHNOLOGY BLVD., #100 | AUSTIN | TX | 78727 |
| K031837 | SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F | AUSTIN | TX | 78727 |
| K031318 | SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F | AUSTIN | TX | 78727 |
| K060132 | SPINAL USA |
213 EASTSIDE LANE | BRANDON | MS | 39047 |
| K030871 | SPINE NEXT SA |
104 GREENWOOD CREEK RD. | QUEENSTOWN | MD | 21658 |
| K030767 | SPINE NEXT SA |
104 GREENWOOD CREEK RD. | QUEENSTOWN | MD | 21658 |
| K033953 | SPINEOLOGY, INC. |
1815 NORTHWESTERN AVE. | STILLWATER | MN | 55082 |
| K020344 | SULZER SPINE-TECH |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55439-2027 |
| K012462 | THEKEN SURGICAL,LLC |
1100 NOLA AVE. | BARBETON | OH | 44203-3819 |
| K012278 | THEKEN SURGICAL,LLC |
1100 NOLA AVE. | BARBETON | OH | 44203-3819 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
