75K Staight Drill
FDA 510(k) K943541 · Stryker Corp.
510(k) numberK943541
Submission
- Device name
- 75K Staight Drill
- Applicant
- Stryker Corp.
Portage, MI, US - Received
- July 22, 1994
- Decision date
- May 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…HBE · Traditional | Surgify Medical OY | 03/26/2026SE |
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| K252060 | GreenHBE · Traditional | Phasor Health, LLC | 10/31/2025SE |
| K252662 | UniBurHBE · Traditional | Nakanishi, Inc. | 09/19/2025SE |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special | Surgify Medical OY | 06/04/2025SE |
| 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 75K Staight Drill cleared by the FDA?
75K Staight Drill (K943541) received a 510(k) decision of Substantially Equivalent on May 18, 1995, 300 days after the submission was received.
What is the product code of K943541?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.