Renovis Anterior Cervical Plate System
FDA 510(k) K152193 · Renovis Surgical Technologies, Inc.
510(k) numberK152193
Submission
- Device name
- Renovis Anterior Cervical Plate System
- Applicant
- Renovis Surgical Technologies, Inc.
Redlands, CA, US - Received
- August 5, 2015
- Decision date
- September 25, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemJWH · Traditional | 06/20/2019SE |
| K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemOVD · Traditional | 12/07/2018SE |
| 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 |
| 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 Anterior Cervical Plate System cleared by the FDA?
Renovis Anterior Cervical Plate System (K152193) received a 510(k) decision of Substantially Equivalent on September 25, 2015, 51 days after the submission was received.
What is the product code of K152193?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.