Vilex Ultima External Fixation System with Ha Coated Pins and Wires
FDA 510(k) K132820 · Vilex, Inc.
510(k) numberK132820
Submission
- Device name
- Vilex Ultima External Fixation System with Ha Coated Pins and Wires
- Applicant
- Vilex, Inc.
Lakewood Ranch, FL, US - Received
- September 9, 2013
- Decision date
- July 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDW – Pin, Fixation, Threaded
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmJDW · Special | Biodynamik, Inc. | 02/10/2026SE |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) SystemJDW · Traditional | Meduloc, LLC | 10/29/2025SE |
| K241357 | XT3 SystemJDW · Traditional | Biodynamik, Inc. | 01/22/2025SE |
| K223112 | MAVERICK Mini External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 12/08/2022SE |
| K213874 | MAVERICK External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 02/11/2022SE |
| K211508 | Steinmann Pins and Kirschner WiresJDW · Traditional | Stryker GmbH | 10/05/2021SE |
| K210784 | Extended HA Half PinsJDW · Special | Smith & Nephew, Inc. | 04/02/2021SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | Syntec Scientific Corporation | 05/05/2020SE |
| K191803 | Orthopedic Fixation PinJDW · Traditional | Tinavi (Anhui) Medical Technologies Co., Ltd. | 04/14/2020SE |
| K192768 | Temporary Fixation PinsJDW · Traditional | Eisertech, LLC | 12/26/2019SE |
More from Eisertech, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K260900 | DYNEX® External Fixation SystemsKTT · Special | 04/17/2026SE |
| K250304 | TITANEX Screw SystemsHWC · Special | 03/05/2025SE |
| K240475 | Hintermann Series H2 Total Ankle SystemHSN · Traditional | 12/02/2024SE |
| K243408 | TACTIX Vector Syndesmosis SystemHTN · Special | 11/27/2024SE |
| K233816 | REDEMPTION Charcot Plating SystemHRS · Traditional | 08/28/2024SE |
| K240035 | TACTIX Vector Syndesmosis SystemHTN · Traditional | 08/01/2024SE |
| K231343 | Redemption Duo Hindfoot Nail SystemHSB · Traditional | 01/30/2024SE |
| K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw SystemHWC · Traditional | 09/11/2023SE |
| K231493 | NITINEX Memory Compression StapleJDR · Traditional | 08/11/2023SE |
| K230462 | OPTIX H2 Patient Specific Instrument SystemHSN · Traditional | 07/17/2023SE |
Questions and answers
When was Vilex Ultima External Fixation System with Ha Coated Pins and Wires cleared by the FDA?
Vilex Ultima External Fixation System with Ha Coated Pins and Wires (K132820) received a 510(k) decision of Substantially Equivalent on July 23, 2014, 317 days after the submission was received.
What is the product code of K132820?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.