OsteoCentric Technologies,Inc
Logan, UT, US
OsteoCentric Technologies,Inc appears in FDA device records in Logan, UT. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for OsteoCentric Technologies,Inc between 2021 and 2025. The busiest year on record is 2023, with 4. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250520 | OsteoCentric Navigated Instruments System | OLO | Substantially Equivalent | |
| K251913 | OsteoCentric® UnifiMI® TCS Plating System | HRS | Substantially Equivalent | |
| K250494 | The OsteoCentric Bone Plate and Screw System | HRS | Substantially Equivalent | |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | HWC | Substantially Equivalent | |
| K230242 | OsteoCentric Dental Implant System | DZE | Substantially Equivalent | |
| K230226 | Integrity-SI® Fusion System | OUR | Substantially Equivalent | |
| K230595 | OsteoCentric ACL Fixation System | HWC | Substantially Equivalent | |
| K230764 | OsteoCentric Integrated Hip Fastener System | JDO | Substantially Equivalent | |
| K222512 | Integrity-SI Fusion System | OUR | Substantially Equivalent | |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener System | NKB | Substantially Equivalent | |
| K211290 | Cannulated Fasteners and Nuts | HWC | Substantially Equivalent | |
| K210754 | Cannulated Fasteners and Nuts | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011656326 | 3011656326 | OsteoCentric Technologies,Inc | 75W 300N, Logan, UT 84321 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- JDODevice, Fixation, Proximal Femoral, Implant
- DZEImplant, Endosseous, Root-Form
- OLOOrthopedic Stereotaxic Instrument
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- OURSacroiliac Joint Fixation
- HWCScrew, Fixation, Bone
- NKBThoracolumbosacral Pedicle Screw System
- HTNWasher, Bolt Nut
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
