Internal Hex Implant System
FDA 510(k) K190837 · Ebi, Inc.
510(k) numberK190837
Submission
- Device name
- Internal Hex Implant System
- Applicant
- Ebi, Inc.
Gyeongsan-Si, KR - Received
- April 1, 2019
- Decision date
- January 22, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Dentis Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K170031 | Internal Octa Implant SystemDZE · Traditional | 08/31/2017SE |
| K142426 | EBI External Implant SystemDZE · Traditional | 03/27/2015SE |
| K140734 | Nextgen Altius Oct SystemKWP · Traditional | 12/15/2014SE |
| K140123 | Polaris Spinal System -Translation ScrewNKB · Traditional | 04/24/2014SE |
| K113796 | Solitaire-C Cervical Spacer SystemOVE · Traditional | 04/26/2012SE |
| K111376 | Construx External Fixation DeviceKTT · Traditional | 08/03/2011SE |
| K073116 | Ebi Internal Implant SystemDZE · Traditional | 02/28/2008SE |
Questions and answers
When was Internal Hex Implant System cleared by the FDA?
Internal Hex Implant System (K190837) received a 510(k) decision of Substantially Equivalent on January 22, 2020, 296 days after the submission was received.
What is the product code of K190837?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.