Stryker Resorbable Fixation System
FDA 510(k) K230733 · Stryker Leibinger GmbH & Co KG
510(k) numberK230733
Submission
- Device name
- Stryker Resorbable Fixation System
- Applicant
- Stryker Leibinger GmbH & Co KG
Freiburg, DE - Received
- March 16, 2023
- Decision date
- August 5, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
More from Stryker Craniomaxillofacial
| 510(k) | Device | Decision |
|---|---|---|
| K261054 | RibPlate SystemHRS · Traditional | 07/01/2026SE |
| K254233 | MEDPOR Customized Implant KitFWP · Special | 03/12/2026SE |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…OLO · Traditional | 02/19/2026SE |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…OLO · Traditional | 02/06/2026SE |
| K243491 | SternalPlate ExpansionHRS · Special | 12/11/2024SE |
| K241517 | Q Guidance System; Mako Spine System;OLO · Traditional | 08/27/2024SE |
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…OLO · Traditional | 07/25/2024SE |
| K240651 | MRI UniversalJEY · Traditional | 07/12/2024SE |
| K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…OLO · Traditional | 06/06/2024SE |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…OLO · Traditional | 03/14/2024SE |
Questions and answers
When was Stryker Resorbable Fixation System cleared by the FDA?
Stryker Resorbable Fixation System (K230733) received a 510(k) decision of Substantially Equivalent on August 5, 2023, 142 days after the submission was received.
What is the product code of K230733?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.