Z-Span Plate System
FDA 510(k) K162824 · Zavation, LLC
510(k) numberK162824
Submission
- Device name
- Z-Span Plate System
- Applicant
- Zavation, LLC
Flowood, MS, US - Received
- October 7, 2016
- Decision date
- February 17, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K162206 | Zavation IBFMAX · Traditional | 04/04/2017SE |
| K162575 | Z-LINKPC SystemNKG · Traditional | 03/03/2017SE |
| K161016 | Z-Clamp ISP SystemPEK · Traditional | 10/19/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | 04/21/2016SE |
| K160362 | Z-Span Plate SystemKWQ · Traditional | 03/22/2016SE |
| K142392 | Zavation Posterior LEIFMAX · Traditional | 04/29/2015SE |
| K142271 | Zavation Z-Link LumbarOVD · Traditional | 12/19/2014SE |
| K141419 | ZvplastyNDN · Traditional | 09/12/2014SE |
| K141005 | Z-Link CervicalOVE · Traditional | 08/07/2014SE |
| K130030 | Zavation Cervical Plate SystemKWQ · Traditional | 04/25/2013SE |
Questions and answers
When was Z-Span Plate System cleared by the FDA?
Z-Span Plate System (K162824) received a 510(k) decision of Substantially Equivalent on February 17, 2017, 133 days after the submission was received.
What is the product code of K162824?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.