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Data / Medical devices / United States / Spinecraft LLC

Spinecraft LLC: FDA-registered device maker in Westmont, IL, United States, 17 510(k) clearances

Spinecraft LLC is registered with the FDA (registration 3004717358) in Westmont, IL, United States. It lists 12 device types. The FDA files 17 510(k) clearances under its listings, the newest dated April 16, 2026. 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.

Get makers like this oneWatch Spinecraft LLC
FDA registration number
3004717358
Address
777 Oakmont Ln Suite 200, Westmont, IL, United States, 60559
Owner or operator
SPINECRAFT LLC (9065601)
Roles
Manufacturer, Specification developer
First device listed
August 5, 2004
Registered through
2026
Brand names listed
ALLTUM Anterior Cervical Plate System, ALTUM Anterior Cervical Plate Instruments, ALTUM Anterior Cervical Plate System, ANTERIS Thoracolumbar Plate System, APEX SPINE SYSTEM, APEX Spine System, APEX Spine System 5.5mm Ti Rod, APEX Spine System Instruments and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufacturer, Specification developeraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Manufacturer, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufacturer, Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufacturer, Specification developeraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Manufacturer, Specification developeraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Manufacturer, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Manufacturer, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 16, 2026K253260ORIO-3D Cage SystemODPSubstantially EquivalentSpineCraftaccessdata.fda.gov
March 4, 2026K260015ANTERIS Thoracolumbar Plate SystemKWQSubstantially EquivalentSpineCraftaccessdata.fda.gov
July 20, 2023K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemOLOSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
December 22, 2022K223273ASTRA Spine SystemNKBSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
September 30, 2021K211935ORIO-Ti Intervertebral Body Fusion Cage SystemODPSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
June 3, 2021K211323ASTRA Spine SystemNKBSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
July 6, 2018K181350ASTRA-OCT Spine SystemNKGSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
May 22, 2015K143683APEX-DL Spine SystemNKBSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
May 19, 2015K150417ASTRA SPINE SYSTEMNKBSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
December 24, 2013K131521VELOX ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
November 20, 2013K132603APEX SPINE SYSTEMNKBSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
July 26, 2011K110906APEX SPINE SYSTEMNKBSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
March 15, 2011K103505ALTUM ANTERIOR CERVICAL PLATEKWQSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
December 10, 2010K102488APEX SPINE SYSTEM W/ COCR RODSMNHSubstantially EquivalentSpinecraft, LLCaccessdata.fda.gov
March 16, 2010K092825APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHERKWPSubstantially EquivalentSpinecraft, Inc.accessdata.fda.gov
October 30, 2009K090887ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGESODPSubstantially EquivalentSpineCraftaccessdata.fda.gov
December 22, 2006K062513APEX SPINE SYSTEMKWPSubstantially EquivalentSpinecraft, Inc.accessdata.fda.gov

Compare with other makers

Updated April 16, 2026. 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.