Tesera-k ALIF System
FDA 510(k) K212980 · Kyocera Medical Technologies, Inc.
510(k) numberK212980
Submission
- Device name
- Tesera-k ALIF System
- Applicant
- Kyocera Medical Technologies, Inc.
Redlands, CA, US - Received
- September 17, 2021
- Decision date
- January 7, 2022
- 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 |
|---|---|---|
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | 07/15/2026SE |
| K242928 | Tesera-k SC SystemOVE · Traditional | 04/10/2025SE |
| K242045 | Initia T3 Acetabular Hemispherical Shell SystemLPH · Traditional | 04/10/2025SE |
| K242771 | Tesera-k PL System and Tesera-k XL SystemMAX · Traditional | 03/20/2025SE |
| K243295 | Initia Knee SystemJWH · Traditional | 01/13/2025SE |
| K243015 | Skyway Anterior Cervical Plate SystemKWQ · Traditional | 11/05/2024SE |
| K232114 | TRIBRID® Unicompartmental Knee SystemHSX · Traditional | 04/04/2024SE |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemOVD · Special | 04/21/2023SE |
| K223105 | Tesera-K SC SystemOVE · Traditional | 12/22/2022SE |
| K212070 | KMTI S141 Lumbar Interbody Fusion SystemMAX · Special | 08/30/2021SE |
Questions and answers
When was Tesera-k ALIF System cleared by the FDA?
Tesera-k ALIF System (K212980) received a 510(k) decision of Substantially Equivalent on January 7, 2022, 112 days after the submission was received.
What is the product code of K212980?
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.