Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K180675
Atlas Spine Expandable Cervical Interbody System · Atlas Spine, Inc. · decided 2018-06-13 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| HiJAK™ Cervical | 2019-08-0010 | ATLAS SPINE, INC. | ODP | M68120190800100 |
| HiJAK™ Cervical | 2019-04-0008 | ATLAS SPINE, INC. | ODP | M68120190400080 |
| HiJAK™ Cervical | 1119-01-0012 | ATLAS SPINE, INC. | ODP | M68111190100120 |
| HiJAK™ Cervical | 1119-02-0013 | ATLAS SPINE, INC. | ODP | M68111190200130 |
| HiJAK™ Cervical | 1119-03-0014 | ATLAS SPINE, INC. | ODP | M68111190300140 |
| HiJAK™ Cervical | 2019-01-0020 | ATLAS SPINE, INC. | ODP | M68120190100200 |
| HiJAK™ Cervical | 2019-08-0013 | ATLAS SPINE, INC. | ODP | M68120190800130 |
| HiJAK™ Cervical | 1119-10-0010 | ATLAS SPINE, INC. | ODP | M68111191000100 |
| HiJAK™ Cervical | 1119-08-0012 | ATLAS SPINE, INC. | ODP | M68111190800120 |
| HiJAK™ Cervical | 2019-01-0013 | ATLAS SPINE, INC. | ODP | M68120190100130 |
| HiJAK™ Cervical | 1119-01-0007 | ATLAS SPINE, INC. | ODP | M68111190100070 |
| HiJAK™ Cervical | 2019-06-0013 | ATLAS SPINE, INC. | ODP | M68120190600130 |
| HiJAK™ Cervical | 2019-04-0009 | ATLAS SPINE, INC. | ODP | M68120190400090 |
| HiJAK™ Cervical | 2019-06-0011 | ATLAS SPINE, INC. | ODP | M68120190600110 |
| HiJAK™ Cervical | 1119-02-0009 | ATLAS SPINE, INC. | ODP | M68111190200090 |
| HiJAK™ Cervical | 2019-01-0011 | ATLAS SPINE, INC. | ODP | M68120190100110 |
| HiJAK™ Cervical | 1119-09-0014 | ATLAS SPINE, INC. | ODP | M68111190900140 |
| HiJAK™ Cervical | 2019-07-0009 | ATLAS SPINE, INC. | ODP | M68120190700090 |
| HiJAK™ Cervical | 2019-02-0013 | ATLAS SPINE, INC. | ODP | M68120190200130 |
| HiJAK™ Cervical | 1119-10-0012 | ATLAS SPINE, INC. | ODP | M68111191000120 |
| HiJAK™ Cervical | 1119-02-0012 | ATLAS SPINE, INC. | ODP | M68111190200120 |
| HiJAK™ Cervical | 2019-04-0013 | ATLAS SPINE, INC. | ODP | M68120190400130 |
| HiJAK™ Cervical | 1119-08-0013 | ATLAS SPINE, INC. | ODP | M68111190800130 |
| HiJAK™ Cervical | 1119-02-0007 | ATLAS SPINE, INC. | ODP | M68111190200070 |
| HiJAK™ Cervical | 1119-07-0010 | ATLAS SPINE, INC. | ODP | M68111190700100 |