OsteoCentric Integrated Hip Fastener System
FDA 510(k) K210247 · Osteocentric Technologies D.B.A. Osteocentric Trauma
510(k) numberK210247
Submission
- Device name
- OsteoCentric Integrated Hip Fastener System
- Applicant
- Osteocentric Technologies D.B.A. Osteocentric Trauma
Logan, UT, US - Received
- January 29, 2021
- Decision date
- April 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|---|
| K230764 | OsteoCentric Integrated Hip Fastener SystemJDO · Special | OsteoCentric Technologies | 04/18/2023SE |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…JDO · Traditional | Smith & Nephew, Inc. | 09/29/2022SE |
| 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 |
Questions and answers
When was OsteoCentric Integrated Hip Fastener System cleared by the FDA?
OsteoCentric Integrated Hip Fastener System (K210247) received a 510(k) decision of Substantially Equivalent on April 30, 2021, 91 days after the submission was received.
What is the product code of K210247?
The FDA product code is JDO – Device, Fixation, Proximal Femoral, Implant, a Class II (moderate risk) device regulated under 21 CFR 888.3030.