ACP 1 Anterior Cervical Plating System
FDA 510(k) K150700 · Stryker Corporation
510(k) numberK150700
Submission
- Device name
- ACP 1 Anterior Cervical Plating System
- Applicant
- Stryker Corporation
Allendale, NJ, US - Received
- March 18, 2015
- Decision date
- July 15, 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 |
|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | 06/29/2026SE |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemHSB · Traditional | 02/03/2026SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | 12/19/2025SE |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB · Traditional | 08/20/2025SE |
| K250163 | T2 Alpha Femur Retrograde Nailing SystemHSB · Traditional | 08/13/2025SE |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…HRS · Traditional | 10/06/2024SE |
| K233919 | VariAx 2 Distal Radius SystemHRS · Traditional | 03/25/2024SE |
| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
| K230045 | HipCheckQIH · Traditional | 09/29/2023SE |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMOWN · Traditional | 09/20/2023SE |
Questions and answers
When was ACP 1 Anterior Cervical Plating System cleared by the FDA?
ACP 1 Anterior Cervical Plating System (K150700) received a 510(k) decision of Substantially Equivalent on July 15, 2015, 119 days after the submission was received.
What is the product code of K150700?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.