Data / Medical devices / United States / Atlas Spine Inc.
Atlas Spine Inc.: FDA-registered device maker in Jupiter, FL, United States, 8 510(k) clearances
Atlas Spine Inc. is registered with the FDA (registration 3003855635) in Jupiter, FL, United States. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated February 28, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003855635
- Address
- 1555 Jupiter Park Dr Ste 1, Jupiter, FL, United States, 33458
- Owner or operator
- ATLAS SPINE INC. (9053705)
- Roles
- Manufacturer
- First device listed
- November 5, 2002
- Registered through
- 2026
- Brand names listed
- Apelo Pedicle Screw System, HiJAK Cervical, HiJAK Cervical Stand Alone, Orthopedic Manual Surgical Instrument, Rebar PEEK, Stature, V3 Plate System, Verteview Plate System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 28, 2020 | K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | OVE | Substantially Equivalent | Atlas Spine, Inc. | accessdata.fda.gov |
| November 29, 2018 | K182418 | V3 Segmental Plating System | KWQ | Substantially Equivalent | Atlas Spine, Inc. | accessdata.fda.gov |
| June 13, 2018 | K180675 | Atlas Spine Expandable Cervical Interbody System | ODP | Substantially Equivalent | Atlas Spine, Inc. | accessdata.fda.gov |
| July 13, 2011 | K110842 | ATLAS SPINE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Atlas Spine, Inc. | accessdata.fda.gov |
| October 2, 2008 | K081880 | ATLAS SPINE SPACER | ODP | Substantially Equivalent | Atlas Spine, Inc. | accessdata.fda.gov |
| October 19, 2007 | K072426 | ATLAS SPINE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Atlas Spine, LLC | accessdata.fda.gov |
| February 26, 2007 | K063205 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | Atlas Spine, LLC | accessdata.fda.gov |
| April 21, 2005 | K050588 | VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Innovative Spinal Design, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 26, 2013 | 73657 | Class II | Terminated | 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. | accessdata.fda.gov |
| June 4, 2009 | 62564 | Class II | Terminated | 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******Tissue Sleeve***MFG Date: | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Thoracolumbosacral Pedicle Screw System
Updated February 28, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.