Anterior Lumbar Buttress System
FDA 510(k) K040130 · Seaspine
510(k) numberK040130
Submission
- Device name
- Anterior Lumbar Buttress System
- Applicant
- Seaspine
San Diego, CA, US - Received
- January 21, 2004
- Decision date
- March 26, 2004
- 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 |
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| K231654 | NorthStar OCT SystemNKG · Traditional | 08/03/2023SE |
| K212135 | Dry DBM- A PuttyMQV · Traditional | 10/04/2021SE |
| K150469 | Integra Laminoplasty SystemNQW · Special | 03/23/2015SE |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…MAX · Traditional | 12/18/2014SE |
| K133418 | Integra Expandable Interverebral Body Fusion Device (Ibd) SystemMAX · Traditional | 05/01/2014SE |
| K132859 | Integra Facet Fixation SystemMRW · Traditional | 11/18/2013SE |
| K121924 | Integra Interspinous Process SystemPEK · Traditional | 09/04/2013SE |
| K130830 | Integra Laminoplasty SystemNQW · Traditional | 05/09/2013SE |
| K122571 | Malibu Spinal System with the Daytona Deformity SystemNKB · Special | 12/12/2012SE |
| K112206 | Cardiff Anterior Cervical Plate SystemKWQ · Special | 01/25/2012SE |
Questions and answers
When was Anterior Lumbar Buttress System cleared by the FDA?
Anterior Lumbar Buttress System (K040130) received a 510(k) decision of Substantially Equivalent on March 26, 2004, 65 days after the submission was received.
What is the product code of K040130?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.