Genesys Spine Binary Lumbar Plate System
FDA 510(k) K173885 · Genesys Spine
510(k) numberK173885
Submission
- Device name
- Genesys Spine Binary Lumbar Plate System
- Applicant
- Genesys Spine
Austin, TX, US - Received
- December 21, 2017
- Decision date
- April 3, 2018
- 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 |
|---|---|---|
| K252322 | SIros-X SystemOUR · Traditional | 10/22/2025SE |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion SystemOVE · Traditional | 02/07/2025SE |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with NavigationOLO · Traditional | 03/29/2024SE |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody SystemOVE · Special | 12/13/2023SE |
| K220096 | Genesys Spine 3DP Lumbar Interbody SystemMAX · Special | 03/09/2022SE |
| K191489 | Genesys Spine 3DP Cervical Interbody SystemOVE · Traditional | 01/08/2020SE |
| K182987 | Genesys Spine 3DP Lumbar Interbody SystemMAX · Traditional | 12/12/2019SE |
| K192678 | Genesys Spine Binary® Lumbar Plate SystemKWQ · Special | 10/24/2019SE |
| K191748 | Genesys Spine Sacroiliac Joint Fusion SystemOUR · Traditional | 09/26/2019SE |
| K192076 | Binary® Anterior Cervical Plate SystemKWQ · Special | 08/29/2019SE |
Questions and answers
When was Genesys Spine Binary Lumbar Plate System cleared by the FDA?
Genesys Spine Binary Lumbar Plate System (K173885) received a 510(k) decision of Substantially Equivalent on April 3, 2018, 103 days after the submission was received.
What is the product code of K173885?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.