Ebi Xfix DFS System
FDA 510(k) K022319 · Ebi, L.P.
510(k) numberK022319
Submission
- Device name
- Ebi Xfix DFS System
- Applicant
- Ebi, L.P.
Parsippany, NJ, US - Received
- July 17, 2002
- Decision date
- August 12, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K100438 | Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemNKB · Special | 06/23/2010SE |
| K100220 | Polaris Spinal SystemNKB · Special | 05/17/2010SE |
| K093880 | Peanut Growth Control Plating SystemHRS · Traditional | 04/16/2010SE |
| K092574 | Esl Spinal SystemMAX · Traditional | 02/04/2010SE |
| K093057 | Biomet Vision Footring SystemKTT · Traditional | 12/01/2009SE |
| K092336 | C-Thru Spinal SystemMQP · Traditional | 10/15/2009SE |
| K091381 | Ibex Spinal SystemMAX · Traditional | 08/07/2009SE |
| K090203 | 5.5 Helical Flange Spinal System, Polaris ComponentsNKB · Special | 07/30/2009SE |
| K090523 | Polaris Spinal SystemNKB · Traditional | 07/01/2009SE |
| K082406 | Expandable Peek-Optima ImplantMAX · Traditional | 01/14/2009SE |
Questions and answers
When was Ebi Xfix DFS System cleared by the FDA?
Ebi Xfix DFS System (K022319) received a 510(k) decision of Substantially Equivalent on August 12, 2002, 26 days after the submission was received.
What is the product code of K022319?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.