Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K192570
Atlas Spine Expandable Cervical Standalone Interbody System · Atlas Spine, Inc. · decided 2020-02-28 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| HiJAK™ Stand Alone | 1123-02-0007 | ATLAS SPINE, INC. | OVE | M68111230200070 |
| HiJAK™ Stand Alone | 1123-04-0008 | ATLAS SPINE, INC. | OVE | M68111230400080 |
| HiJAK™ Stand Alone | 1123-02-0011 | ATLAS SPINE, INC. | OVE | M68111230200110 |
| HiJAK™ Stand Alone | 1123-03-0014 | ATLAS SPINE, INC. | OVE | M68111230300140 |
| HiJAK™ Stand Alone | 1123-03-0009 | ATLAS SPINE, INC. | OVE | M68111230300090 |
| HiJAK™ Stand Alone | 1123-02-0014 | ATLAS SPINE, INC. | OVE | M68111230200140 |
| HiJAK™ Stand Alone | 1123-01-0009 | ATLAS SPINE, INC. | OVE | M68111230100090 |
| HiJAK™ Stand Alone | 1123-03-0012 | ATLAS SPINE, INC. | OVE | M68111230300120 |
| HiJAK™ Stand Alone | 1123-04-0011 | ATLAS SPINE, INC. | OVE | M68111230400110 |
| HiJAK™ Stand Alone | 1123-03-0013 | ATLAS SPINE, INC. | OVE | M68111230300130 |
| HiJAK™ Stand Alone | 1123-02-0009 | ATLAS SPINE, INC. | OVE | M68111230200090 |
| HiJAK™ Stand Alone | 1123-04-0009 | ATLAS SPINE, INC. | OVE | M68111230400090 |
| HiJAK™ Stand Alone | 1123-01-0014 | ATLAS SPINE, INC. | OVE | M68111230100140 |
| HiJAK™ Stand Alone | 1123-01-0012 | ATLAS SPINE, INC. | OVE | M68111230100120 |
| HiJAK™ Stand Alone | 1123-04-0014 | ATLAS SPINE, INC. | OVE | M68111230400140 |
| HiJAK™ Stand Alone | 1123-02-0013 | ATLAS SPINE, INC. | OVE | M68111230200130 |
| HiJAK™ Stand Alone | 1123-02-0010 | ATLAS SPINE, INC. | OVE | M68111230200100 |
| HiJAK™ Stand Alone | 1123-03-0011 | ATLAS SPINE, INC. | OVE | M68111230300110 |
| HiJAK™ Stand Alone | 1123-02-0008 | ATLAS SPINE, INC. | OVE | M68111230200080 |
| HiJAK™ Stand Alone | 1123-01-0007 | ATLAS SPINE, INC. | OVE | M68111230100070 |
| HiJAK™ Stand Alone | 1123-03-0008 | ATLAS SPINE, INC. | OVE | M68111230300080 |
| HiJAK™ Stand Alone | 1123-01-0011 | ATLAS SPINE, INC. | OVE | M68111230100110 |
| HiJAK™ Stand Alone | 1123-01-0013 | ATLAS SPINE, INC. | OVE | M68111230100130 |
| HiJAK™ Stand Alone | 1123-01-0010 | ATLAS SPINE, INC. | OVE | M68111230100100 |
| HiJAK™ Stand Alone | 1123-01-0008 | ATLAS SPINE, INC. | OVE | M68111230100080 |