FDA 510(k) Applications for Medical Device:
Posterior Metal/Polymer Spinal System, Fusion
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K072321 | BIOSPINE CO., LTD. |
1331 H STREET NW, 12TH FLOOR | WASHINGTON | DC | 20005 |
| K031511 | CENTERPULSE SPINE-TECH, INC. |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55439-2027 |
| K073439 | GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K061304 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K182928 | Medtronic Sofamor Danek USA, Inc. |
1800 Pyramid Place | Memphis | TN | 38132 |
| K203678 | Medtronic Sofamor Danek USA, INC. |
1800 Pyramid Place | Memphis | TN | 38132 |
| K191066 | Medtronic Sofamor Danek, USA Inc. |
1800 Pyramid Place | Memphis | TN | 38132 |
| K061774 | N SPINE, INC. |
13221 MARICOTTE PLACE | SAN DIEGO | CA | 92130 |
| K072685 | N SPINE, INC. |
6244 FERRIS SQUARE, SUITE B | SAN DIEGO | CA | 92121-3239 |
| K080963 | PARADIGM SPINE |
1331 H STREET NW | WASHINGTON | DC | 20005 |
| K101083 | PARADIGM SPINE LLC |
1331 H STREET NW 12TH FLOOR | WASHINGTON | DC | 20005 |
| K080241 | PARADIGM SPINE, LLC |
1331 H STREET NW | WASHINGTON | DC | 20005 |
| K072969 | PARADIGM SPINE, LLC |
1331 H STREET NW | WASHINGTON | DC | 20005 |
| K091944 | PARADIGM SPINE, LLC |
1331 H STREET NW | WASHINGTON | DC | 20005 |
| K071261 | SCIENT'X |
1015 MAITLAND CENTER COMMONS | MAITLAND | FL | 32751 |
| K060638 | ZIMMER SPINE, INC |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55439-2027 |
| K073347 | ZIMMER SPINE, INC |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55439-2027 |
| K092234 | ZIMMER SPINE, INC |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55439-2027 |
| K133164 | ZIMMER SPINE, INC |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55441 |
| K043565 | ZIMMER SPINE, INC |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55439-2027 |
| K071879 | ZIMMER SPINE, INC |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55441 |
| K101704 | ZIMMER SPINE, INC. |
7375 BUSH LAKE RD. | MINNEAPOLIS | MN | 55439 |
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