Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K212937
Dakota ALIF Plate System · Precision Spine, Inc. · decided 2021-11-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Dakota ALIF Plate System | 69-BK-4000 | PRECISION SPINE, INC. | KWQ | 00840019968379 |
| Dakota ALIF Plate System | 69-SC-0313 | PRECISION SPINE, INC. | KWQ | 00840019968164 |
| Dakota ALIF Plate System | 69-PA-0013 | PRECISION SPINE, INC. | KWQ | 00840019963978 |
| Dakota ALIF Plate System | 69-SD-5535 | PRECISION SPINE, INC. | KWQ | 00840019964081 |
| Dakota ALIF Plate System | 69-BK-0302 | PRECISION SPINE, INC. | KWQ | 00840019968201 |
| Dakota ALIF Plate System | 69-BK-0303 | PRECISION SPINE, INC. | KWQ | 00840019968218 |
| Dakota ALIF Plate System | 69-SD-5025 | PRECISION SPINE, INC. | KWQ | 00840019964029 |
| Dakota ALIF Plate System | 69-SD-5530 | PRECISION SPINE, INC. | KWQ | 00840019964074 |
| Dakota ALIF Plate System | 69-PA-0019 | PRECISION SPINE, INC. | KWQ | 00840019964005 |
| Dakota ALIF Plate System | 69-SC-0315 | PRECISION SPINE, INC. | KWQ | 00840019968188 |
| Dakota ALIF Plate System | 69-SC-0311 | PRECISION SPINE, INC. | KWQ | 00840019968140 |
| Dakota ALIF Plate System | 69-SD-5020 | PRECISION SPINE, INC. | KWQ | 00840019964012 |
| Dakota ALIF Plate System | 69-SD-5030 | PRECISION SPINE, INC. | KWQ | 00840019964036 |
| Dakota ALIF Plate System | 69-PA-0015 | PRECISION SPINE, INC. | KWQ | 00840019963985 |
| Dakota ALIF Plate System | 69-SC-4000 | PRECISION SPINE, INC. | KWQ | 00840019968362 |
| Dakota ALIF Plate System | 69-PA-0017 | PRECISION SPINE, INC. | KWQ | 00840019963992 |
| Dakota ALIF Plate System | 69-SC-2000 | PRECISION SPINE, INC. | KWQ | 00840019968317 |
| Dakota ALIF Plate System | 69-SC-5000 | PRECISION SPINE, INC. | KWQ | 00840019968386 |
| Dakota ALIF Plate System | 69-BK-2000 | PRECISION SPINE, INC. | KWQ | 00840019968324 |
| Dakota ALIF Plate System | 69-SC-0314 | PRECISION SPINE, INC. | KWQ | 00840019968171 |
| Dakota ALIF Plate System | 69-SC-0312 | PRECISION SPINE, INC. | KWQ | 00840019968157 |
| Dakota ALIF Plate System | 69-BK-5009 | PRECISION SPINE, INC. | KWQ | 00840019968409 |
| Dakota ALIF Plate System | 69-SD-5035 | PRECISION SPINE, INC. | KWQ | 00840019964043 |
| Dakota ALIF Plate System | 69-SD-5525 | PRECISION SPINE, INC. | KWQ | 00840019964067 |
| Dakota ALIF Plate System | 69-BK-2001 | PRECISION SPINE, INC. | KWQ | 00840019968331 |