Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K132191
SP-FIX SPINOUS PROCESS FIXATION PLATE · Globus Medical, Inc. · decided 2013-11-22 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SP-FIX | 588.132 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092370 |
| SP-FIX | 588.126 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092356 |
| SP-FIX | 588.150 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092431 |
| SP-FIX | 588.138 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092394 |
| SP-FIX | 188.722 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092080 |
| SP-FIX | 588.144 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092417 |
| SP-FIX | 588.147 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092424 |
| SP-FIX | 188.026 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044091588 |
| SP-FIX | 688.172 | GLOBUS MEDICAL, INC. | LXH | 00849044092622 |
| SP-FIX | 188.426 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044091885 |
| SP-FIX | 188.326 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044091786 |
| SP-FIX | 588.141 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092400 |
| SP-FIX | 588.135 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092387 |
| SP-FIX | 188.126 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044091687 |
| SP-FIX | 688.226 | GLOBUS MEDICAL, INC. | LXH | 00849044092639 |
| SP-FIX | 588.155 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092448 |
| SP-FIX | 588.026 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092257 |
| SP-FIX | 588.129 | GLOBUS MEDICAL, INC. | KWP PEK | 00849044092363 |
| SP-FIX | 688.122 | GLOBUS MEDICAL, INC. | LXH | 00849044092547 |