OsteoCentric Technologies,Inc

FDA Device Registration & Listing · Logan, UT, US · Registration 3011656326

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011656326
FEI Number
3011656326
Entity Name
OsteoCentric Technologies,Inc
City/State/Country
Logan, UT, US
Establishment Address
75W 300N, Suite 150, Logan, UT 84321, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
OsteoCentric Technologies Inc (Owner Number: 10049507)
Owner / Operator Contact Address
75W 300N, Suite 150, Logan, UT 84321, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

OsteoCentric Technologies Cancellous Bone Screw Fastener System OsteoCentric Trauma Cancellous Bone Screw Fastener System OsteoCentric Technologies Bone Fastener OsteoCentric Trauma Bone Fastener OsteoCentric Bone Plate and Fastener System OsteoCentric Extremities Headless Compression System OsteoCentric Technologies Headless Compression System OsteoCentric Trauma Headless Compression System OsteoCentric Technologies Bone Screw OsteoCentric Trauma Bone Screw OsteoCentric Navigated Instruments System OsteoCentric Integrity SI fusion System OsteoCentric Technologies Schanz Screw OsteoCentric Trauma Schanz Screw OsteoCentric Technologies Cannulated Fasteners and Nuts OsteoCentric Technologies Integrated Hip Fastener System OsteoCentric Technologies Plate and Screw System OsteoCentric Trauma Plate and Screw System OsteoCentric Integrity SI fusion System OsteoCentric Technologies Bone Plate and Screw System OsteoCentric Trauma Bone Plate and Screw System OsteoCentric Spine MIS Pedicle Fastener System OsteoCentric Technologies Integrity-SI Fusion System OsteoCentric UnifiMI TCS Plating System OsteoCentric Technologies Cannulated System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-07-18
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2018-07-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-06-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-03-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-03-31
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-03-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-05-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-23
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2021-12-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-03-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-11-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-11-12
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-05-03
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2021-05-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-12-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-12-03
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2022-09-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-03-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-03-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-09-12
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2023-09-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-09-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-09-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-05-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-05-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OsteoCentric Technologies Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011656326. Last updated year: 2026. Please use registration number 3011656326 when referencing this establishment in official correspondence.
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