Stella Cervical Plate
FDA 510(k) K052763 · Scient'X
510(k) numberK052763
Submission
- Device name
- Stella Cervical Plate
- Applicant
- Scient'X
Round Rock, TX, US - Received
- September 30, 2005
- Decision date
- November 10, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K071261 | Isobar Semi-Rigid Dual DampenerNQP · Traditional | 04/17/2008SE |
| K062912 | Scient'X Spinal SystemMNI · Special | 02/05/2007SE |
| K052367 | Scient'X Cement RestrictorJDK · Traditional | 10/05/2005SESU |
| K050348 | Co Vertebral Body ReplacementMQP · Special | 05/27/2005SE |
| K051063 | Polyaxial Hemispherical Spinal ScrewsMNI · Special | 05/23/2005SE |
| K043001 | MX Polyaxial Pedicle ScrewMNH · Special | 12/01/2004SE |
| K042964 | MX Monoaxial Pedicle ScrewMNH · Special | 11/22/2004SE |
| K042317 | Cervical PlateKWQ · Special | 09/24/2004SE |
| K040747 | Aladyn Rigid Spine PlateMNH · Special | 06/17/2004SE |
| K040454 | Biofill Bone Void FillerMQV · Traditional | 05/07/2004SE |
Questions and answers
When was Stella Cervical Plate cleared by the FDA?
Stella Cervical Plate (K052763) received a 510(k) decision of Substantially Equivalent on November 10, 2005, 41 days after the submission was received.
What is the product code of K052763?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.