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Data / Medical devices / United States / Republic Spine

Republic Spine: FDA-registered device maker in Fort Lauderdale, FL, United States, 6 510(k) clearances

Republic Spine is registered with the FDA (registration 3011796723) in Fort Lauderdale, FL, United States. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 26, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Republic Spine
FDA registration number
3011796723
Address
100 NE Third Avenue STE 120, Fort Lauderdale, FL, United States, 33301
Owner or operator
Republic Spine (10049873)
Roles
Complaint file establishment, Manufacturer
First device listed
August 18, 2015
Registered through
2026
Brand names listed
Dark Star Deformity Pedicle Screw System, Darkstar Navigation Instrument System, Republic Spine Dark Star Spinal System, Restore Cervical Interbody Fusion, Restore Lumbar Interbody Fusion

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Manufactureraccessdata.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
May 26, 2023K223096Dark Star Deformity Pedicle Screw SystemNKBSubstantially EquivalentRepublic Spine, LLCaccessdata.fda.gov
September 27, 2021K212028Dark Star Navigation Instrument SystemOLOSubstantially EquivalentRepublic Spine, LLCaccessdata.fda.gov
September 12, 2019K190398Republic Spine Restore Intervertebral Body Fusion SystemMAXSubstantially EquivalentRepublic Spine, LLCaccessdata.fda.gov
June 19, 2019K190889Republic Spine Restore Cervical Interbody Fusion SystemODPSubstantially EquivalentRepublic Spine, LLCaccessdata.fda.gov
July 25, 2018K181495Republic Spine Dark Star Spinal SystemNKBSubstantially EquivalentRepublic Spine, LLCaccessdata.fda.gov
April 29, 2015K150283Republic Spine Dark Star Spinal SystemMNHSubstantially EquivalentRepublic Spine, LLCaccessdata.fda.gov

Compare with other makers

Updated May 26, 2023. 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.