M-2 Anterior Plate System
FDA 510(k) K972718 · Acromed Corp.
510(k) numberK972718
Submission
- Device name
- M-2 Anterior Plate System
- Applicant
- Acromed Corp.
Cleveland, OH, US - Received
- July 21, 1997
- Decision date
- October 1, 1997
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K980485 | Isola Spinal SystemMNI · Traditional | 10/21/1998SE |
| K981714 | Timx Low Back System Titanium MX Rod Based Low Back SystemMNH · Traditional | 06/30/1998SE |
| K981113 | Pediatric PRCMNH · Traditional | 05/29/1998SE |
| K981274 | Acromed Timx Plate Based Low Back SystemMNH · Special | 04/29/1998SE |
| K980228 | University Plate Anterior SystemKWQ · Traditional | 04/14/1998SN |
| K974757 | Kaneda Anterior Scoliosis System KassKWQ · Traditional | 03/05/1998SN |
| K971248 | Kaneda SR Anterior Spinal SystemKWQ · Traditional | 06/11/1997SN |
| K970955 | Acromed Anterior Cervical Stabilization SystemKWQ · Traditional | 06/11/1997SN |
| K970950 | Easy RodMNH · Traditional | 06/03/1997SE |
| K965102 | Acromed Pedicle ScrewMNH · Traditional | 05/08/1997SE |
Questions and answers
When was M-2 Anterior Plate System cleared by the FDA?
M-2 Anterior Plate System (K972718) received a 510(k) decision of Substantially Equivalent for Some Indications on October 1, 1997, 72 days after the submission was received.
What is the product code of K972718?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.