FDA Registration
Active
🇺🇸 United States
OsteoCentric Technologies,Inc
Reg #: 3011656326
·
FEI: 3011656326
·
Expires 2026
Products
12
Proprietary Names
32
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- OsteoCentric Technologies,Inc
- Registration Number
- 3011656326
- FEI Number
- 3011656326
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 75W 300N, Suite 150
- City
- Logan
- State
- UT
- ZIP
- 84321
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160946
Owner / Operator
- Firm Name
- OsteoCentric Technologies Inc
- Operator Number
- 10049507
- Address
- 75W 300N, Suite 150
- City
- Logan
- State
- UT
- Postal Code
- 84321
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-07-18 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2018-07-18 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-03-31 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2025-03-31 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-03-23 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2021-12-22 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2021-05-03 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2021-05-03 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-09-12 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2019-03-29 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2023-10-11 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2023-10-11 |
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 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
OsteoCentric Technologies K-Wire and Pins
OsteoCentric Trauma K-Wire and Pins
OsteoCentric Femoral Neck Fracture System
OsteoCentric ACL Fixation Fastener System
OsteoCentric Dental Implant System
OsteoCentric Technologies Cannulated Bone Screw Fastener System
OsteoCentric Trauma Cannulated Bone Screw Fastener System
OsteoCentric Technologies Cannulated Fastener System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility