Idys ALIF ZP 3DTi
FDA 510(k) K192168 · Clariance, Sas
510(k) numberK192168
Submission
- Device name
- Idys ALIF ZP 3DTi
- Applicant
- Clariance, Sas
Beaurains, FR - Received
- August 9, 2019
- Decision date
- November 4, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
More from Alphatec Spine
| 510(k) | Device | Decision |
|---|---|---|
| K243904 | Elegance® Anterior Cervical plateKWQ · Special | 01/14/2025SE |
| K243670 | Idys® LIFMAX · Special | 12/31/2024SE |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MISNKB · Special | 07/24/2024SE |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemNKB · Special | 04/26/2024SE |
| K240715 | Idys® C ZP 3DTiOVE · Special | 03/22/2024SE |
| K220182 | Aggeris-CKWQ · Traditional | 03/30/2022SE |
| K212562 | Idys-C ZP 3DTiOVE · Traditional | 10/12/2021SE |
| K200919 | Idys ALIF 3DTiMAX · Traditional | 04/12/2021SE |
| K202032 | Idys LLIF 3DTiOVD · Traditional | 04/01/2021SE |
| K202956 | Erisma LP Navigated InstrumentsOLO · Traditional | 02/26/2021SE |
Questions and answers
When was Idys ALIF ZP 3DTi cleared by the FDA?
Idys ALIF ZP 3DTi (K192168) received a 510(k) decision of Substantially Equivalent on November 4, 2019, 87 days after the submission was received.
What is the product code of K192168?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.