Atlas Spine, Inc.
Jupiter, FL, US
ATLAS SPINE INC. appears in FDA device records in Jupiter, FL. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Atlas Spine, Inc. between 2007 and 2026. The busiest year on record is 2007, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 4 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2017 | 2 |
| 2018 | 2 |
| 2020 | 2 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252822 | Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant | PLR | Substantially Equivalent | |
| K252560 | Atlas Spine HiRISE™ Expandable Cervical Corpectomy System | PLR | Substantially Equivalent | |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | MAX | Substantially Equivalent | |
| K243191 | Atlas Spine Lateral Expandable Interbody System | OVD | Substantially Equivalent | |
| K202302 | Atlas Spine Rebar (Ti) Spacer System | ODP | Substantially Equivalent | |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | OVE | Substantially Equivalent | |
| K182418 | V3 Segmental Plating System | KWQ | Substantially Equivalent | |
| K180675 | Atlas Spine Expandable Cervical Interbody System | ODP | Substantially Equivalent | |
| K172334 | Ortus™ Expandable Lumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K162918 | Atlas Spine Expandable Interbody System | MAX | Substantially Equivalent | |
| K112759 | APCLO PEDICLE SCREW SYSTEMS | NKB | Substantially Equivalent | |
| K110842 | ATLAS SPINE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K100743 | ATLAS SPINE PIVOTING SYSTEM | MAX | Substantially Equivalent | |
| K091406 | ATLAS SPINE SPACER | MQP | Substantially Equivalent | |
| K081880 | ATLAS SPINE SPACER | ODP | Substantially Equivalent | |
| K072426 | ATLAS SPINE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K071497 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | |
| K063464 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | |
| K063205 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003855635 | 3003855635 | ATLAS SPINE INC. | 1555 Jupiter Park Dr Ste 1, JUPITER, FL 33458 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- MQPSpinal Vertebral Body Replacement Device
- PLRSpinal Vertebral Body Replacement Device - Cervical
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1616-2016 | Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position | The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. | Class II | Terminated | |
| Z-2274-2012 | Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain