JEC — Component, Traction, Invasive Class II
FDA Device Classification
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 |