Pinehurst Anterior Cervical Plate System
FDA 510(k) K181190 · Signature Orthopaedics Pty, Ltd.
510(k) numberK181190
Submission
- Device name
- Pinehurst Anterior Cervical Plate System
- Applicant
- Signature Orthopaedics Pty, Ltd.
Lane Cove West, AU - Received
- May 4, 2018
- Decision date
- January 17, 2019
- 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
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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 |
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| K251771 | Cambridge Partial KneeHSX · Traditional | 12/16/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | 08/07/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | 05/13/2025SE |
| K242477 | Shoulder Soft Tissue AnchorsMBI · Traditional | 05/12/2025SE |
| K243043 | Origin Cemented Hip StemLZO · Traditional | 05/02/2025SE |
| K243029 | Origin TT StemLZO · Traditional | 03/11/2025SE |
| K243162 | World LinerMEH · Special | 11/25/2024SE |
| K240683 | Rx Knee SystemJWH · Traditional | 09/11/2024SE |
Questions and answers
When was Pinehurst Anterior Cervical Plate System cleared by the FDA?
Pinehurst Anterior Cervical Plate System (K181190) received a 510(k) decision of Substantially Equivalent on January 17, 2019, 258 days after the submission was received.
What is the product code of K181190?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.