Pass Anterior Spinal System
FDA 510(k) K102406 · Medicrea Technologies
510(k) numberK102406
Submission
- Device name
- Pass Anterior Spinal System
- Applicant
- Medicrea Technologies
Round Rock, TX, US - Received
- August 24, 2010
- Decision date
- August 23, 2011
- 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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| 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 |
|---|---|---|
| K100544 | Impix Lumbar Interbody DeviceMAX · Special | 07/22/2010SE |
| K083798 | Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMAX · Traditional | 05/19/2010SE |
| K100297 | Pass LP Spinal SystemMNI · Traditional | 03/04/2010SE |
| K083810 | Pass LP Spinal SystemMNI · Special | 07/31/2009SE |
| K083308 | Pass LP Spinal SystemMNI · Special | 12/10/2008SE |
| K082577 | Pass LP Spinal SystemMNH · Special | 10/03/2008SE |
| K082069 | Pass 2 Spinal SystemMNI · Special | 10/03/2008SE |
| K080099 | Pass Spinal SystemMNI · Special | 04/09/2008SE |
| K072226 | Impix SpacerMAX · Traditional | 12/10/2007SE |
| K070530 | Modification to Passmed Spinal SystemMNH · Special | 10/18/2007SE |
Questions and answers
When was Pass Anterior Spinal System cleared by the FDA?
Pass Anterior Spinal System (K102406) received a 510(k) decision of Substantially Equivalent on August 23, 2011, 364 days after the submission was received.
What is the product code of K102406?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.