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Data / Medical devices / United States / Osseus Fusion Systems LLC

Osseus Fusion Systems LLC: FDA-registered device maker in Dallas, TX, United States, 11 510(k) clearances

Osseus Fusion Systems LLC is registered with the FDA (registration 3010531060) in Dallas, TX, United States. It lists 37 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 21, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Osseus Fusion Systems LLC
FDA registration number
3010531060
Address
1931 Greenville Avenue Suite 200, Dallas, TX, United States, 75206
Owner or operator
OSSEUS FUSION SYSTEMS LLC (10045353)
Roles
Repackager or relabeler, Specification developer
First device listed
November 7, 2013
Registered through
2027
Brand names listed
11MM DRILL, CANNULATED, 11MM WASHER, 11X35MM IMPLANT, 11X40MM IMPLANT, 11X45MM IMPLANT, 11X50MM IMPLANT, 11X55MM IMPLANT, 11X60MM IMPLANT and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Repackager or relabeler, Specification developeraccessdata.fda.gov
Applier, CerclageHXN1Repackager or relabeler, Specification developeraccessdata.fda.gov
AwlHWJ1Repackager or relabeler, Specification developeraccessdata.fda.gov
BenderHXW1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeler, Specification developeraccessdata.fda.gov
CaliperKTZ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Crimper, PinHXQ1Repackager or relabeler, Specification developeraccessdata.fda.gov
CuretteHTF1Repackager or relabeler, Specification developeraccessdata.fda.gov
Forceps, Wire HoldingHYA1Repackager or relabeleraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, CompressionHWN1Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Repackager or relabeler, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Repackager or relabeler, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Specification developeraccessdata.fda.gov
MalletHXL1Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Repackager or relabeler, Specification developeraccessdata.fda.gov
Pliers, SurgicalHTC1Repackager or relabeleraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Specification developeraccessdata.fda.gov
ProbeHXB1Repackager or relabeleraccessdata.fda.gov
RaspHTR1Repackager or relabeler, Specification developeraccessdata.fda.gov
ReamerHTO1Repackager or relabeler, Specification developeraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Repackager or relabeler, Specification developeraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Repackager or relabeler, Specification developeraccessdata.fda.gov
TampHXG1Repackager or relabeler, Specification developeraccessdata.fda.gov
Tap, BoneHWX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Repackager or relabeler, Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeler, Specification developeraccessdata.fda.gov
WrenchHXC1Repackager or relabeler, 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
August 21, 2026K261882Pisces-SC Standalone Cervical Interbody SystemOVESubstantially EquivalentOsseus Fusions Systems, LLCaccessdata.fda.gov
November 3, 2022K222107Black Diamond™ POCT Spinal SystemNKGSubstantially EquivalentOsseus Fusion Systemsaccessdata.fda.gov
May 6, 2022K213935PISCES-SA Standalone ALIF Interbody SystemOVDSubstantially EquivalentOsseus Fusion Systemsaccessdata.fda.gov
March 1, 2022K213590Blue Topaz Sacroiliac Screw SystemOURSubstantially EquivalentOsseus Fusion Systems, LLCaccessdata.fda.gov
January 17, 2020K192495Black Diamond Navigation InstrumentsOLOSubstantially EquivalentOsseus Fusion Systemsaccessdata.fda.gov
October 29, 2019K192121Black Diamond Pedicle Screw SystemNKBSubstantially EquivalentOsseus Fusion Systemsaccessdata.fda.gov
October 3, 2018K181881Outlet Sacroiliac Joint Fusion SystemOURSubstantially EquivalentSij Surgicalaccessdata.fda.gov
August 15, 2018K181347Aries® Lumbar InterbodiesMAXSubstantially EquivalentOsseus Fusion Systems, LLCaccessdata.fda.gov
July 3, 2017K170844Gemini-C Hybrid Cervical Interbody SystemODPSubstantially EquivalentOsseus Fusion Systems, LLCaccessdata.fda.gov
April 26, 2016K160522White Pearl Preferred Angle Anterior Cervical PlateKWQSubstantially EquivalentOsseus Fusion Systems, LLCaccessdata.fda.gov
August 8, 2013K131810OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEMMNHSubstantially EquivalentOsseus Fusion Systems, LLCaccessdata.fda.gov

Compare with other makers

Updated August 21, 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.