OsteoCentric Integrated Hip Fastener System
FDA 510(k) K230764 · OsteoCentric Technologies
510(k) numberK230764
Submission
- Device name
- OsteoCentric Integrated Hip Fastener System
- Applicant
- OsteoCentric Technologies
Logan, UT, US - Received
- March 20, 2023
- Decision date
- April 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDO – Device, Fixation, Proximal Femoral, Implant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…JDO · Traditional | Smith & Nephew, Inc. | 09/29/2022SE |
| K210247 | OsteoCentric Integrated Hip Fastener SystemJDO · Traditional | Osteocentric Technologies D.B.A. Osteocentric… | 04/30/2021SE |
| K193029 | Conquest FNJDO · Traditional | Smith & Nephew, Inc. | 02/28/2020SE |
| K173826 | THP Hip Fracture Plating SystemJDO · Traditional | Biomet, Inc. | 02/07/2018SE |
| K172785 | Conquest FNJDO · Special | Smith & Nephew | 12/22/2017SE |
| K152686 | Conquest FNJDO · Traditional | Smith & Nephew | 03/17/2016SE |
| K140018 | TSP Hip Fracture Plating SystemJDO · Traditional | Biomet, Inc. | 04/04/2014SE |
| K080685 | Hiploc Compression Hip ScrewJDO · Traditional | Biomet Manufacturing, Inc. | 08/15/2008SE |
| K080434 | Intertan CHS Locking Plate System Prox Fem Plates/ScrewJDO · Traditional | Smith & Nephew, Inc. | 04/10/2008SE |
| K983814 | Gotfried Percutaneous Compression Plating SystemJDO · Traditional | Efratgo, Ltd. HI Tech Bio-Surgical | 01/14/1999SE |
More from Efratgo, Ltd. HI Tech Bio-Surgical
| 510(k) | Device | Decision |
|---|---|---|
| K250520 | OsteoCentric Navigated Instruments SystemOLO · Traditional | 10/27/2025SE |
| K251913 | OsteoCentric® UnifiMI® TCS Plating SystemHRS · Special | 08/16/2025SE |
| K250494 | The OsteoCentric Bone Plate and Screw SystemHRS · Special | 03/18/2025SE |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and NutsHWC · Special | 10/09/2024SE |
| K230242 | OsteoCentric Dental Implant SystemDZE · Traditional | 10/05/2023SE |
| K230226 | Integrity-SI® Fusion SystemOUR · Special | 09/21/2023SE |
| K230595 | OsteoCentric ACL Fixation SystemHWC · Traditional | 06/29/2023SE |
| K222512 | Integrity-SI Fusion SystemOUR · Special | 09/12/2022SE |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener SystemNKB · Traditional | 07/28/2022SE |
| K211290 | Cannulated Fasteners and NutsHWC · Special | 08/03/2021SE |
Questions and answers
When was OsteoCentric Integrated Hip Fastener System cleared by the FDA?
OsteoCentric Integrated Hip Fastener System (K230764) received a 510(k) decision of Substantially Equivalent on April 18, 2023, 29 days after the submission was received.
What is the product code of K230764?
The FDA product code is JDO – Device, Fixation, Proximal Femoral, Implant, a Class II (moderate risk) device regulated under 21 CFR 888.3030.