Michelson Anterior Cervical Plate System
FDA 510(k) K974435 · Wrightmedicaltechnologyinc
510(k) numberK974435
Submission
- Device name
- Michelson Anterior Cervical Plate System
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- November 24, 1997
- Decision date
- February 19, 1998
- 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 |
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| 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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Questions and answers
When was Michelson Anterior Cervical Plate System cleared by the FDA?
Michelson Anterior Cervical Plate System (K974435) received a 510(k) decision of Substantially Equivalent for Some Indications on February 19, 1998, 87 days after the submission was received.
What is the product code of K974435?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.