MP LeFort I Plates
FDA 510(k) K171364 · Stryker
510(k) numberK171364
Submission
- Device name
- MP LeFort I Plates
- Applicant
- Stryker
Portage, MI, US - Received
- May 9, 2017
- Decision date
- July 24, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JEY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…JEY · Traditional | KLS-Martin L.P. | 08/17/2026SE |
| K253206 | METICULY Patient-specific CMF solutionJEY · Traditional | Meticuly Co., Ltd. | 07/25/2026SE |
| 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 |
| K232350 | Stryker Facial iD SystemJEY · Traditional | Stryker Craniomaxillofacial | 01/13/2024SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | 06/29/2026SE |
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| K253202 | Hoffmann LRF SystemKTT · Traditional | 12/19/2025SE |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB · Traditional | 08/20/2025SE |
| K250163 | T2 Alpha Femur Retrograde Nailing SystemHSB · Traditional | 08/13/2025SE |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…HRS · Traditional | 10/06/2024SE |
| K233919 | VariAx 2 Distal Radius SystemHRS · Traditional | 03/25/2024SE |
| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
| K230045 | HipCheckQIH · Traditional | 09/29/2023SE |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMOWN · Traditional | 09/20/2023SE |
Questions and answers
When was MP LeFort I Plates cleared by the FDA?
MP LeFort I Plates (K171364) received a 510(k) decision of Substantially Equivalent on July 24, 2017, 76 days after the submission was received.
What is the product code of K171364?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.