BALTEUM - ONE Lumbar Plate System
FDA 510(k) K213820 · Huvexel Co. , Ltd.
510(k) numberK213820
Submission
- Device name
- BALTEUM - ONE Lumbar Plate System
- Applicant
- Huvexel Co. , Ltd.
Seongnam-Si, KR - Received
- December 8, 2021
- Decision date
- March 25, 2022
- 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 |
|---|---|---|
| K200846 | Balteum Lumbar Plate SystemKWQ · Traditional | 05/05/2020SE |
| K191477 | AEON-C Stand Alone SystemOVE · Traditional | 11/13/2019SE |
| K180729 | FaSet Fixation SystemMRW · Traditional | 06/28/2018SE |
| K173201 | UNITY Sacroiliac Joint Fixation SystemOUR · Traditional | 04/26/2018SE |
| K173131 | Rexious Spinal Fixation SystemNKB · Special | 12/08/2017SE |
| K173099 | Fortis and Hana Anterior Cervical Plate SystemKWQ · Traditional | 11/30/2017SE |
| K173080 | IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)MAX · Special | 10/31/2017SE |
Questions and answers
When was BALTEUM - ONE Lumbar Plate System cleared by the FDA?
BALTEUM - ONE Lumbar Plate System (K213820) received a 510(k) decision of Substantially Equivalent on March 25, 2022, 107 days after the submission was received.
What is the product code of K213820?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.