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Data / Medical devices / United States / OsteoCentric Technologies,Inc

OsteoCentric Technologies,Inc: FDA-registered device maker in Logan, UT, United States, 24 510(k) clearances

OsteoCentric Technologies,Inc is registered with the FDA (registration 3011656326) in Logan, UT, United States. It lists 12 device types. The FDA files 24 510(k) clearances under its listings, the newest dated October 2, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch OsteoCentric Technologies,Inc
FDA registration number
3011656326
Address
75W 300N Suite 150, Logan, UT, United States, 84321
Owner or operator
OsteoCentric Technologies Inc (10049507)
Roles
Complaint file establishment, Specification developer
First device listed
June 10, 2015
Registered through
2027
Brand names listed
OsteoCentric ACL Fixation Fastener System, OsteoCentric Bone Plate and Fastener System, OsteoCentric Dental Implant System, OsteoCentric Extremities Headless Compression System, OsteoCentric Femoral Neck Fracture System, OsteoCentric Integrity SI fusion System, OsteoCentric Navigated Instruments System, OsteoCentric Spine MIS Pedicle Fastener System and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Complaint file establishment, Specification developeraccessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Complaint file establishment, Specification developeraccessdata.fda.gov
Device, Fixation, Proximal Femoral, ImplantJDO2Complaint file establishment, Specification developeraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Complaint file establishment, Specification developeraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Complaint file establishment, Specification developeraccessdata.fda.gov
Plate, Fixation, BoneHRS2Complaint file establishment, Specification developeraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Complaint file establishment, Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Complaint file establishment, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Specification developeraccessdata.fda.gov
Washer, Bolt NutHTN2Complaint file establishment, 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
October 2, 2026K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsHWCSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
October 27, 2025K250520OsteoCentric Navigated Instruments SystemOLOSubstantially EquivalentOsteocentric Technologies, Inc.accessdata.fda.gov
August 16, 2025K251913OsteoCentric® UnifiMI® TCS Plating SystemHRSSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
March 18, 2025K250494The OsteoCentric Bone Plate and Screw SystemHRSSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
October 9, 2024K242691OsteoCentric Technologies Cannulated Fasteners and NutsHWCSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
October 5, 2023K230242OsteoCentric Dental Implant SystemDZESubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
September 21, 2023K230226Integrity-SI® Fusion SystemOURSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
June 29, 2023K230595OsteoCentric ACL Fixation SystemHWCSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
April 18, 2023K230764OsteoCentric Integrated Hip Fastener SystemJDOSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
September 12, 2022K222512Integrity-SI Fusion SystemOURSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
July 28, 2022K221332OsteoCentric Spine MIS Pedicle Fastener SystemNKBSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
August 3, 2021K211290Cannulated Fasteners and NutsHWCSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
April 30, 2021K210247OsteoCentric Integrated Hip Fastener SystemJDOSubstantially EquivalentOsteocentric Technologies D.B.A. Osteocentric Traumaaccessdata.fda.gov
April 14, 2021K210754Cannulated Fasteners and NutsHWCSubstantially EquivalentOsteoCentric Technologiesaccessdata.fda.gov
May 4, 2020K200259Headless Compression Screw SystemHWCSubstantially EquivalentOsteocentric Extremities, LLCaccessdata.fda.gov
March 22, 2019K190430OsteoCentric Bone Plate and Screw SystemHWCSubstantially EquivalentOsteocentric Traumaaccessdata.fda.gov
October 25, 2018K182171SMV Scientific K-Wire and PinsJDWSubstantially EquivalentSummit Medventuresaccessdata.fda.gov
May 22, 2017K170021SMV Scientific Cannulated ScrewsHWCSubstantially EquivalentSmv Scientificaccessdata.fda.gov
December 14, 2016K161755Integrity-SI TM Fusion SystemOURSubstantially EquivalentCoorstek Medicalaccessdata.fda.gov
December 5, 2016K1609464.0 and 6.5 Cancellous Bone Screw and WasherHWCSubstantially EquivalentSmv Scientificaccessdata.fda.gov
March 28, 2016K160603SMV Scientific Schanz ScrewsHWCSubstantially EquivalentSmv Scientificaccessdata.fda.gov
November 25, 2015K152000SMV Scientific Bone Plate and Screw SystemHRSSubstantially EquivalentSmv Scientificaccessdata.fda.gov
June 23, 2015K150981SMV Scientific Bone ScrewsHWCSubstantially EquivalentSmv Scientificaccessdata.fda.gov
April 29, 2015K150188SMV Scientific 4.5 mm Bone ScrewsHWCSubstantially EquivalentSummit Medventuresaccessdata.fda.gov

Compare with other makers

Updated October 2, 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.