Kaneda Anterior Scoliosis System Kass
FDA 510(k) K974757 · Acromed Corp.
510(k) numberK974757
Submission
- Device name
- Kaneda Anterior Scoliosis System Kass
- Applicant
- Acromed Corp.
Cleveland, OH, US - Received
- December 19, 1997
- Decision date
- March 5, 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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| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
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| 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 |
| K972718 | M-2 Anterior Plate SystemKWQ · Traditional | 10/01/1997SN |
| 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 Kaneda Anterior Scoliosis System Kass cleared by the FDA?
Kaneda Anterior Scoliosis System Kass (K974757) received a 510(k) decision of Substantially Equivalent for Some Indications on March 5, 1998, 76 days after the submission was received.
What is the product code of K974757?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.