JDO — Device, Fixation, Proximal Femoral, Implant Class II
FDA product code JDO covers "Device, Fixation, Proximal Femoral, Implant", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JDO
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230764 | Osteocentric Technologies | OsteoCentric Integrated Hip Fastener System | Apr 18, 2023 |
| K213126 | Smith And Nephew | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, V | Sep 29, 2022 |
| K210247 | Osteocentric Technologies D.B.A. Osteocentric Trauma | OsteoCentric Integrated Hip Fastener System | Apr 30, 2021 |
| K193029 | Smith And Nephew | CONQUEST FN | Feb 28, 2020 |
| K173826 | Biomet | THP Hip Fracture Plating System | Feb 7, 2018 |
| K172785 | Smith And Nephew | CONQUEST FN | Dec 22, 2017 |
| K152686 | Smith And Nephew | CONQUEST FN | Mar 17, 2016 |
| K140018 | Biomet | TSP HIP FRACTURE PLATING SYSTEM | Apr 4, 2014 |
| K080685 | Biomet Manufacturing | HIPLOC COMPRESSION HIP SCREW | Aug 15, 2008 |
| K080434 | Smith And Nephew | INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW | Apr 10, 2008 |
| K983814 | Efratgo, Ltd. Hi Tech Bio-Surgical | GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM | Jan 14, 1999 |
| K981757 | Synthes (Usa) | SYNTHES (USA) DHS HELIX SYSTEM | Jul 17, 1998 |
| K964259 | Synthes (Usa) | SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION | Jan 9, 1997 |
| K962644 | Deutschland Surgical | VIGOR COMPRESSION HIP SCREW SYSTEM | Sep 6, 1996 |
| K953607 | Synthes (Usa) | TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) | Mar 8, 1996 |
| K951904 | Synthes (Usa) | SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] | Jul 17, 1995 |
| K934161 | Stelkast | PROFORM HIP SYSTEM | Mar 10, 1994 |
| K934162 | Stelkast | PROFORM HA HIP SYSTEM | Mar 9, 1994 |
| K923613 | Synthes (Usa) | SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT | Jun 22, 1993 |
| K831076 | Kirschner Medical | COMPRESSION SYSTEM | Apr 28, 1983 |