Altus Spine Cervical Plate System
FDA 510(k) K163061 · Altus Partners, LLC
510(k) numberK163061
Submission
- Device name
- Altus Spine Cervical Plate System
- Applicant
- Altus Partners, LLC
West Chester, PA, US - Received
- November 1, 2016
- Decision date
- February 6, 2017
- 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 |
|---|---|---|
| K243419 | Altus Spine Navigation SystemOLO · Traditional | 05/08/2025SE |
| K211027 | Altus Spine Pedicle Screw SystemNKB · Traditional | 09/16/2022SE |
| K211837 | Altus Spine Interbody Standalone Fusion SystemOVD · Traditional | 04/19/2022SE |
| K210887 | Altus Spine Sochi OCT Spinal SystemNKG · Traditional | 08/20/2021SE |
| K200922 | Altus Spine HA Pedicle Screw SystemNKB · Special | 01/26/2021SE |
| K200322 | Altus Spine Pedicle Screw SystemNKB · Traditional | 06/02/2020SE |
| K183084 | Fuji Cervical Plate SystemKWQ · Special | 05/29/2019SE |
| K182406 | Altus Spine Interbody Fusion SystemMAX · Traditional | 02/22/2019SE |
| K181339 | Altus Spine Pedicle Screw SystemNKB · Traditional | 07/24/2018SE |
| K181281 | Altus Spine Pedicle Screw SystemNKB · Special | 06/11/2018SE |
Questions and answers
When was Altus Spine Cervical Plate System cleared by the FDA?
Altus Spine Cervical Plate System (K163061) received a 510(k) decision of Substantially Equivalent on February 6, 2017, 97 days after the submission was received.
What is the product code of K163061?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.