Butrex Lumbar Buttress Plating System
FDA 510(k) K170530 · X-Spine Systems, Inc.
510(k) numberK170530
Submission
- Device name
- Butrex Lumbar Buttress Plating System
- Applicant
- X-Spine Systems, Inc.
Miamisburg, OH, US - Received
- February 22, 2017
- Decision date
- March 22, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K173832 | InTice-C Porous Ti Cervical Interbody SystemODP · Traditional | 05/17/2018SE |
| K180153 | X-spine Cortical Bone Screw SystemNKB · Traditional | 03/15/2018SE |
| K170119 | Calix Lumbar Spinal Implant SystemMAX · Traditional | 09/29/2017SE |
| K171567 | IRIX-A Lumbar Integrated Fusion SystemOVD · Traditional | 08/28/2017SE |
| K171075 | Calix-C Cervical Interbody SpacerODP · Traditional | 08/01/2017SE |
| K170224 | Spider Cervical Plating SystemKWQ · Traditional | 07/06/2017SE |
| K160959 | Xsert Lumbar Expandable Interbody SystemMAX · Traditional | 11/17/2016SE |
| K162944 | Irix-C Cervical Integrated Fusion SystemOVE · Traditional | 11/07/2016SE |
| K160428 | Certex Spinal Fixation SystemNKG · Traditional | 05/05/2016SE |
| K160114 | Xspan Laminoplasty Fixation SystemNQW · Traditional | 03/15/2016SE |
Questions and answers
When was Butrex Lumbar Buttress Plating System cleared by the FDA?
Butrex Lumbar Buttress Plating System (K170530) received a 510(k) decision of Substantially Equivalent on March 22, 2017, 28 days after the submission was received.
What is the product code of K170530?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.