Matira Anterior Cervical System
FDA 510(k) K172086 · Kalitec Direct, LLC
510(k) numberK172086
Submission
- Device name
- Matira Anterior Cervical System
- Applicant
- Kalitec Direct, LLC
Orlando, FL, US - Received
- July 11, 2017
- Decision date
- September 22, 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
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 |
|---|---|---|
| K180401 | TiWAVE-C Porous Titanium Cervical CageODP · Traditional | 06/14/2018SE |
| K172808 | CosmoLock Pedicle Screw SystemNKB · Traditional | 10/25/2017SE |
| K170342 | Ocata Anterior Cervical SystemKWQ · Traditional | 05/09/2017SE |
| K163471 | Kalitec Direct InSePtion MIS Fixation SystemPEK · Traditional | 03/16/2017SE |
| K140678 | Cosmolock Pedicle Screw SystemMNH · Traditional | 06/19/2014SE |
| K133815 | Intess Cervical Cage SystemODP · Traditional | 04/16/2014SE |
| K123100 | Intess Lumbar CageMAX · Traditional | 03/28/2013SE |
| K111370 | Odalys Pedicle Screw SystemMNH · Traditional | 09/21/2011SE |
Questions and answers
When was Matira Anterior Cervical System cleared by the FDA?
Matira Anterior Cervical System (K172086) received a 510(k) decision of Substantially Equivalent on September 22, 2017, 73 days after the submission was received.
What is the product code of K172086?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.