Stryker Facial iD System
FDA 510(k) K232350 · Stryker Craniomaxillofacial
510(k) numberK232350
Submission
- Device name
- Stryker Facial iD System
- Applicant
- Stryker Craniomaxillofacial
Portage, MI, US - Received
- August 7, 2023
- Decision date
- January 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…JEY · Traditional | KLS-Martin L.P. | 08/17/2026SE |
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| K252246 | Leforte MMF SystemJEY · Traditional | Jeil Medical Corporation | 04/02/2026SE |
| K253373 | Southern Craniomaxillofacial (CMF) SystemJEY · Traditional | Southern Medical (Pty) , Ltd. | 12/19/2025SE |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…JEY · Traditional | Inion OY | 11/07/2025SE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional | KLS-Martin L.P. | 08/16/2024SE |
| K240651 | MRI UniversalJEY · Traditional | Stryker Leibinger GmbH & Co KG | 07/12/2024SE |
| K233874 | tmCMF SolutionJEY · Traditional | Techmah Cmf | 07/11/2024SE |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implantJEY · Traditional | Meticuly Co., Ltd. | 04/30/2024SE |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemJEY · Traditional | Medcad | 09/26/2023SE |
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Questions and answers
When was Stryker Facial iD System cleared by the FDA?
Stryker Facial iD System (K232350) received a 510(k) decision of Substantially Equivalent on January 13, 2024, 159 days after the submission was received.
What is the product code of K232350?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.