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Sign in to claim this brandATLAS SPINE INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1555 Jupiter Park Dr Ste 1, JUPITER, FL, 33458
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003855635
- DUNS Number
- —
Catalogue (910)
Page 18 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Verteview® | VSS-046-010 | FDA UDI | Class II | Active |
| True Position® | True Position® | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1106-02-5530 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1106-05-0000 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1110-02-8550 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1110-02-8540 | FDA UDI | Class II | Active |
| HiJAK™ Cervical | 2019-01-0004 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1110-01-6555 | FDA UDI | Class II | Active |
| HiJAK™ Cervical | 2019-07-0011 | FDA UDI | Class II | Active |
| Verteview® | VSA-300-060 | FDA UDI | Class II | Active |
| True Position® | True Position® | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1100-05-4854 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1100-08-0085 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1106-03-6545 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1100-08-0060 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 2006-13-0425 | FDA UDI | Class I | Active |
| Apelo® / Apelo® MIS | 1100-16-0500 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1100-08-0075 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1100-10-0110 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1100-01-0200 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1110-01-5535 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 2006-15-0000 | FDA UDI | Class I | Active |
| Apelo® / Apelo® MIS | 6906-33-0450 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1110-02-5535 | FDA UDI | Class II | Active |
| True Position® | True Position® | FDA UDI | Class II | Active |
| HiJAK™ Cervical | 1119-01-0009 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1110-02-8560 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1100-10-0050 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1100-01-0045 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1106-01-6555 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1106-03-7545 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1110-03-4540 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 2006-05-0000 | FDA UDI | Class I | Active |
| True Position® | True Position® | FDA UDI | Class II | Active |
| HiJAK™ Cervical | 2019-09-0009 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1100-05-0022 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 2006-64-0000 | FDA UDI | Class I | Active |
| Apelo® / Apelo® MIS | 2006-13-0825 | FDA UDI | Class I | Active |
| Apelo® / Apelo® MIS | 1100-16-0090 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1106-02-7540 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 1106-03-5530 | FDA UDI | Class II | Active |
| Apelo® / Apelo® MIS | 2006-46-0000 | FDA UDI | Class I | Active |
| Atlas Spine Vertebral Body Replacement | K071497 | FDA 510(k) | Class II | Active |
| Atlas Spine Expandable Interbody System | K162918 | FDA 510(k) | Class II | Active |
| Atlas Spine Lateral Expandable Interbody System | K243191 | FDA 510(k) | Class II | Active |
| Atlas Spine Spacer | K081880 | FDA 510(k) | Class II | Active |
| Atlas Spine Pedicle Screw System | K110842 | FDA 510(k) | Class II | Active |
| Atlas Spine Pedicle Screw System | K072426 | FDA 510(k) | Class II | Active |
| Atlas Spine Project X Expandable Posterior Lumbar Interbody System | K251969 | FDA 510(k) | Class II | Active |
| Atlas Spine Expandable Cervical Standalone Interbody System | K192570 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 26, 2013 | Z-1616-2016 | — | terminated | The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. |
| Jun 4, 2009 | Z-2274-2012 | — | terminated | Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery. |