Medical Device Manufacturer · US , Logan , UT

OsteoCentric Technologies

11 submissions · 11 cleared · Since 2021
11
Total
11
Cleared
0
Denied

OsteoCentric Technologies — FDA 510(k) Submissions

OsteoCentric Technologies has submitted 11 FDA 510(k) premarket notifications since 2021, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Screw, Fixation, Bone, Sacroiliac Joint Fixation, Plate, Fixation, Bone, Thoracolumbosacral Pedicle Screw System, Implant, Endosseous, Root-form . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
OsteoCentric? UnifiMI? TCS Plating System
K251913 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2025 54d
The OsteoCentric Bone Plate and Screw System
K250494 · HRS Plate, Fixation, Bone · Orthopedic
Mar 2025 26d
OsteoCentric Technologies Cannulated Fasteners and Nuts
K242691 · HWC Screw, Fixation, Bone · Orthopedic
Oct 2024 30d
OsteoCentric Dental Implant System
K230242 · DZE Implant, Endosseous,... · Dental
Oct 2023 248d
Integrity-SI? Fusion System
K230226 · OUR Sacroiliac Joint Fixation · Orthopedic
Sep 2023 237d
OsteoCentric ACL Fixation System
K230595 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2023 118d
OsteoCentric Integrated Hip Fastener System
K230764 · JDO Device, Fixation,... · Orthopedic
Apr 2023 29d
Integrity-SI Fusion System
K222512 · OUR Sacroiliac Joint Fixation · Orthopedic
Sep 2022 24d
OsteoCentric Spine MIS Pedicle Fastener System
K221332 · NKB Thoracolumbosacral... · Orthopedic
Jul 2022 80d
Cannulated Fasteners and Nuts
K211290 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2021 97d
Cannulated Fasteners and Nuts
K210754 · HWC Screw, Fixation, Bone · Orthopedic
Apr 2021 30d
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