Stryker iBur hubs and cutting accessories
FDA 510(k) K210377 · Stryker Corporation
510(k) numberK210377
Submission
- Device name
- Stryker iBur hubs and cutting accessories
- Applicant
- Stryker Corporation
Portage, MI, US - Received
- February 9, 2021
- Decision date
- June 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252060 | GreenHBE · Traditional | Phasor Health, LLC | 10/31/2025SE |
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| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special | Surgify Medical OY | 03/13/2025SE |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special | Stryker Instruments | 03/11/2025SE |
| K232684 | Surgify HaloHBE · Traditional | Surgify Medical OY | 11/29/2023SE |
| K230619 | Hubly Electric Drill (H100)HBE · Traditional | Hubly, Inc. | 05/04/2023SE |
| K223199 | 2.1 x 255mm Drill, 22mm StopHBE · Special | Biomet Microfixation | 11/15/2022SE |
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| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
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Questions and answers
When was Stryker iBur hubs and cutting accessories cleared by the FDA?
Stryker iBur hubs and cutting accessories (K210377) received a 510(k) decision of Substantially Equivalent on June 30, 2021, 141 days after the submission was received.
What is the product code of K210377?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.