Bone Screw
FDA 510(k) K251569 · Osstem Implant Co., Ltd.
510(k) numberK251569
Submission
- Device name
- Bone Screw
- Applicant
- Osstem Implant Co., Ltd.
Busan, KR - Received
- May 22, 2025
- Decision date
- August 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K254286 | Guided Bone Regeneration SystemDZL · Traditional | DentalMaster(Xiamen)Medical Technology Co., Ltd. | 08/24/2026SE |
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)DZL · Traditional | Hager& Meisinger GmbH | 09/29/2025SE |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PINDZL · Traditional | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 06/27/2025SE |
| K233419 | GBR SystemDZL · Traditional | Proimtech Saglik Urunleri Anonim Sirketi | 01/03/2025SE |
| K240321 | MP Pin flat without thread (36BMP000020/MP20)DZL · Traditional | Hager& Meisinger GmbH | 10/17/2024SE |
| K233721 | KLS Martin Drill-Free MMF ScrewDZL · Traditional | KLS-Martin L.P. | 09/17/2024SE |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS ScrewsDZL · Traditional | Stryker Leibinger GmbH & Co KG | 08/24/2023SE |
| K222367 | Save GBRDZL · Traditional | Dentis Co., Ltd. | 03/23/2023SE |
| K201210 | The Micro Screw System, Micro Screw System BasicDZL · Traditional | Hager& Meisinger GmbH | 10/08/2021SE |
| K201561 | Membrane Screws and Membrane TacksDZL · Traditional | Neoss Limited | 10/05/2020SE |
More from Neoss Limited
| 510(k) | Device | Decision |
|---|---|---|
| K251434 | Healing Abutment SystemNHA · Traditional | 03/04/2026SE |
| K242521 | Estar-ZEEIH · Traditional | 11/20/2024SE |
| K233806 | T2 PlusOAS · Traditional | 09/06/2024SE |
| K233194 | TS Abutment SystemNHA · Traditional | 02/20/2024SE |
| K232220 | SS Abutment SystemNHA · Traditional | 12/05/2023SE |
| K232012 | N1EHD · Traditional | 11/28/2023SE |
| K222778 | Osstem Implant SystemDZE · Traditional | 09/23/2023SE |
| K221684 | Osstem Abutment SystemNHA · Traditional | 09/08/2022SE |
| K212303 | T2OAS · Traditional | 09/21/2021SE |
| K210097 | Estar-ZEIH · Traditional | 07/02/2021SE |
Questions and answers
When was Bone Screw cleared by the FDA?
Bone Screw (K251569) received a 510(k) decision of Substantially Equivalent on August 13, 2025, 83 days after the submission was received.
What is the product code of K251569?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.