Captiva Spine SmartLOX Cervical Plate System
FDA 510(k) K141332 · Captiva Spine
510(k) numberK141332
Submission
- Device name
- Captiva Spine SmartLOX Cervical Plate System
- Applicant
- Captiva Spine
Jupiter, FL, US - Received
- May 21, 2014
- Decision date
- June 11, 2015
- 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 |
|---|---|---|
| K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw SystemNKB · Special | 01/31/2020SE |
| K181229 | TirboLOX-C Cervical IBFDODP · Traditional | 09/19/2018SE |
| K180990 | TirboLOX-L Lumbar IBFDMAX · Traditional | 08/13/2018SE |
| K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw SystemNKB · Traditional | 03/19/2018SE |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | 03/02/2016SE |
| K151116 | CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special | 06/26/2015SE |
| K142586 | Captiva Spine FuselOX Cervical IBF SystemODP · Traditional | 05/28/2015SE |
| K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemMNH · Special | 08/08/2013SE |
| K122956 | Fuselox Lumbar Interbody Fusion DeviceMAX · Special | 10/25/2012SE |
| K122332 | Towerlox Pedicle Screw SystemMNI · Special | 10/16/2012SE |
Questions and answers
When was Captiva Spine SmartLOX Cervical Plate System cleared by the FDA?
Captiva Spine SmartLOX Cervical Plate System (K141332) received a 510(k) decision of Substantially Equivalent on June 11, 2015, 386 days after the submission was received.
What is the product code of K141332?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.