Thoracic Anterior Spinal Fixation Plate
FDA 510(k) K910874 · Terray Manufacturing, Inc.
510(k) numberK910874
Submission
- Device name
- Thoracic Anterior Spinal Fixation Plate
- Applicant
- Terray Manufacturing, Inc.
Ontario K7s 1l8, CA - Received
- March 1, 1991
- Decision date
- February 3, 1992
- Decision
- Substantially Equivalent (SESE)
- 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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| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
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| 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 |
|---|---|---|
| K882934 | Casf Cancellous Bone Screw, BT650HWC · Traditional | 10/13/1988SE |
| K882871 | Casf Drill Guide DG 170LYQ · Traditional | 09/23/1988SN |
| K883193 | Casf Sterilization TrayFSM · Traditional | 08/10/1988SE |
| K883125 | Casf Sterilization TrayFSM · Traditional | 08/10/1988SE |
| K870085 | Anterior Spinal Fixation PlateKWP · Traditional | 06/30/1987SE |
| K870082 | Bone PlateHRS · Traditional | 05/06/1987SE |
| K870083 | Ferray ExtractorHWB · Traditional | 02/26/1987SE |
| K870084 | RD 140 Surgical BenderHXW · Traditional | 01/28/1987SE |
Questions and answers
When was Thoracic Anterior Spinal Fixation Plate cleared by the FDA?
Thoracic Anterior Spinal Fixation Plate (K910874) received a 510(k) decision of Substantially Equivalent on February 3, 1992, 339 days after the submission was received.
What is the product code of K910874?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.