Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
FDA 510(k) K182007 · Renovis Surgical Technologies
510(k) numberK182007
Submission
- Device name
- Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
- Applicant
- Renovis Surgical Technologies
Redlands, CA, US - Received
- July 27, 2018
- Decision date
- December 7, 2018
- 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 |
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| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemJWH · Traditional | 06/20/2019SE |
| K181655 | Renovis S180 Lateral Lumbar Interbody Fusion SystemMAX · Traditional | 09/11/2018SE |
| K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) SystemOVD · Traditional | 06/14/2018SE |
| K171543 | Renovis Surgical Hip Replacement SystemOQG · Traditional | 11/16/2017SE |
| K170888 | Renovis S141 Lumbar Interbody Fusion SystemMAX · Traditional | 08/08/2017SE |
| K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemOVE · Traditional | 03/16/2016SE |
| K152193 | Renovis Anterior Cervical Plate SystemKWQ · Traditional | 09/25/2015SE |
| K143647 | Renovis Surgical Hip Replacement SystemOQG · Traditional | 05/11/2015SE |
| K143126 | Renovis S141 Lumbar Interbody Cage SystemMAX · Traditional | 02/06/2015SE |
| K141676 | Renovis Surgical Porous Acetabular Cup SystemLPH · Traditional | 11/04/2014SE |
Questions and answers
When was Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System cleared by the FDA?
Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System (K182007) received a 510(k) decision of Substantially Equivalent on December 7, 2018, 133 days after the submission was received.
What is the product code of K182007?
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.