DigiFix Sterile Kit
FDA 510(k) K192465 · Virak Orthopedics, LLC
510(k) numberK192465
Submission
- Device name
- DigiFix Sterile Kit
- Applicant
- Virak Orthopedics, LLC
Harrison, NJ, US - Received
- September 9, 2019
- Decision date
- October 10, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JEC – Component, Traction, Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JEC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203605 | SteriTrakJEC · Traditional | Arbutus Medical, Inc. | 04/23/2021SE |
| K193256 | Anjon Bremer Halo SystemJEC · Traditional | Anjon Holdings, LLC | 03/02/2020SE |
| K181192 | PIP FixJEC · Traditional | Hand Biomechanics Lab, Inc. | 10/22/2018SE |
| K171863 | Anjon Bremer Halo SystemJEC · Traditional | Anjon Holdings, LLC | 03/19/2018SE |
| K163028 | Medline ReNewal Reprocessed Stryker External Fixation DevicesJEC · Traditional | Surgical Instrument Service and Savings, Inc. | 12/28/2016SE |
| K132731 | Digifix External Fixation SystemJEC · Traditional | Virak Orthopedic Research, LLC | 01/10/2014SE |
| K102885 | Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020…JEC · Special | Stryker Corp. | 01/14/2011SE |
| K082679 | Laki Hand Fixation System, Model TFX.3X.06.XJEC · Special | Sintea Biotech, Inc. | 04/07/2009SE |
| K072432 | F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non SterileJEC · Traditional | Hand Biomechanics Lab, Inc. | 01/09/2008SE |
| K071476 | Synthes (USA) 2ND Generation Pelvic C-ClampJEC · Traditional | Synthes (Usa) | 08/24/2007SE |
Questions and answers
When was DigiFix Sterile Kit cleared by the FDA?
DigiFix Sterile Kit (K192465) received a 510(k) decision of Substantially Equivalent on October 10, 2019, 31 days after the submission was received.
What is the product code of K192465?
The FDA product code is JEC – Component, Traction, Invasive, a Class II (moderate risk) device regulated under 21 CFR 888.3040.