KLS Martin Drill-Free MMF Screw
FDA 510(k) K233721 · KLS-Martin L.P.
510(k) numberK233721
Submission
- Device name
- KLS Martin Drill-Free MMF Screw
- Applicant
- KLS-Martin L.P.
Jacksonville, FL, US - Received
- November 21, 2023
- Decision date
- September 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K240321 | MP Pin flat without thread (36BMP000020/MP20)DZL · Traditional | Hager& Meisinger GmbH | 10/17/2024SE |
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| K222367 | Save GBRDZL · Traditional | Dentis Co., Ltd. | 03/23/2023SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…JEY · Traditional | 08/17/2026SE |
| K254162 | KLS Martin Ixos SystemHRS · Traditional | 02/20/2026SE |
| K253660 | KLS Martin Pure Pectus SystemHRS · Traditional | 02/20/2026SE |
| K250988 | KLS Martin Pure Pectus SystemHRS · Traditional | 12/11/2025SE |
| K250865 | KLS Martin IPS Forearm SystemHRS · Traditional | 11/14/2025SE |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…GXN · Traditional | 11/10/2025SE |
| K250620 | KLS Martin Ixos SystemHRS · Traditional | 08/15/2025SE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional | 08/16/2024SE |
| K241018 | KLS Martin Orthopedic Implants - MR ConditionalHRS · Traditional | 07/12/2024SE |
| K230211 | CranioXpandPBJ · Traditional | 11/21/2023SE |
Questions and answers
When was KLS Martin Drill-Free MMF Screw cleared by the FDA?
KLS Martin Drill-Free MMF Screw (K233721) received a 510(k) decision of Substantially Equivalent on September 17, 2024, 301 days after the submission was received.
What is the product code of K233721?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.