Quintex Cervical Plating System
FDA 510(k) K121801 · Aesculap Implant Systems, LLC
510(k) numberK121801
Submission
- Device name
- Quintex Cervical Plating System
- Applicant
- Aesculap Implant Systems, LLC
Center Valley, PA, US - Received
- June 19, 2012
- Decision date
- September 11, 2012
- 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 |
|---|---|---|
| K213871 | Ennovate Cervical Spinal and Occiput SystemNKG · Traditional | 07/01/2022SE |
| K210963 | ENNOVATE Spinal SystemNKB · Traditional | 07/19/2021SE |
| K180433 | Ennovate®NKB · Traditional | 04/26/2018SE |
| K162134 | ENNOVATE Spinal SystemNKB · Traditional | 12/14/2016SE |
| K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsOLO · Traditional | 07/08/2016SE |
| K153629 | ArcadiusXP C Spinal SystemOVE · Traditional | 05/25/2016SE |
| K153396 | Aesculap OrthoPilot Next GenerationOLO · Traditional | 05/16/2016SE |
| K151938 | S4 Cervical Spinal and Occiput SystemsNKG · Traditional | 10/21/2015SE |
| K151056 | Aesculap T-Space PEEK and XP Spinal SystemMAX · Traditional | 08/13/2015SE |
| K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee SystemJWH · Special | 05/29/2015SE |
Questions and answers
When was Quintex Cervical Plating System cleared by the FDA?
Quintex Cervical Plating System (K121801) received a 510(k) decision of Substantially Equivalent on September 11, 2012, 84 days after the submission was received.
What is the product code of K121801?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.