JEC — Component, Traction, Invasive Class II
FDA product code JEC covers "Component, Traction, Invasive", a Class II medical device regulated under 21 CFR 888.3040. 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
- JEC
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203605 | arbutus medical | SteriTrak | April 23, 2021 |
| K193256 | anjon holdings | Anjon Bremer Halo System | March 2, 2020 |
| K192465 | virak orthopedics | DigiFix Sterile Kit | October 10, 2019 |
| K181192 | hand biomechanics lab | PIP Fix | October 22, 2018 |
| K171863 | anjon holdings | Anjon Bremer Halo System | March 19, 2018 |
| K163028 | surgical instrument service and savings | Medline ReNewal Reprocessed Stryker External Fixation Devices | December 28, 2016 |
| K132731 | virak orthopedic research | DIGIFIX EXTERNAL FIXATION SYSTEM | January 10, 2014 |
| K102885 | stryker | HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020 | January 14, 2011 |
| K082679 | sintea biotech | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X | April 7, 2009 |
| K072432 | hand biomechanics lab | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | January 9, 2008 |
| K071476 | synthes (usa) | SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP | August 24, 2007 |
| K042066 | kls-martin l.p | KLSA MARTIN HAND DISTRACTOR | August 25, 2004 |
| K032427 | meridan medical | FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM | October 9, 2003 |
| K031941 | howmedica osteonics | HOFFMANN II COMPACT BALTIMORE COUPLING | July 24, 2003 |
| K030519 | hand biomechanics lab | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, C | June 10, 2003 |
| K022676 | smith and nephew | ORTHOGUARD AB ANTIMICROBIAL SLEEVE | September 23, 2002 |
| K022065 | sintea biotech | SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X | August 6, 2002 |
| K012193 | smith and nephew | AMC ANTIMICROBIAL PIN/WIRE SLEEVE | July 11, 2002 |
| K013818 | autogenesis | AUTOGENESIS AUTOMATOR, MODEL M1000 | December 5, 2001 |
| K003848 | howmedica osteonics | HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST | January 11, 2001 |