MedCAD AccuShape Titanium Patient-Specific Cranial Implant
FDA 510(k) K220357 · Medcad
510(k) numberK220357
Submission
- Device name
- MedCAD AccuShape Titanium Patient-Specific Cranial Implant
- Applicant
- Medcad
Dallas, TX, US - Received
- February 8, 2022
- Decision date
- August 26, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Meticuly Co., Ltd.
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| K252064 | MedCAD® AccuStride SystemPBF · Traditional | 03/27/2026SE |
| K251709 | MedCAD® AccuStride SystemPBF · Traditional | 11/04/2025SE |
| K241811 | MedCAD® AccuStride SystemPBF · Traditional | 03/13/2025SE |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemJEY · Traditional | 09/26/2023SE |
| K223421 | MedCAD AccuPlan Orthopedics SystemPBF · Traditional | 09/20/2023SE |
| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | 03/07/2023SE |
| K193280 | MedCAD® AccuPlate® Patient-Specific PlateJEY · Traditional | 02/12/2021SE |
| K192282 | MedCAD® AccuPlan® SystemDZJ · Traditional | 10/29/2020SE |
Questions and answers
When was MedCAD AccuShape Titanium Patient-Specific Cranial Implant cleared by the FDA?
MedCAD AccuShape Titanium Patient-Specific Cranial Implant (K220357) received a 510(k) decision of Substantially Equivalent on August 26, 2022, 199 days after the submission was received.
What is the product code of K220357?
The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.