Modified Sterilization of Drills, Burrs, Trephines
FDA 510(k) K900388 · Midas Rex Pneumatic Tools, Inc.
510(k) numberK900388
Submission
- Device name
- Modified Sterilization of Drills, Burrs, Trephines
- Applicant
- Midas Rex Pneumatic Tools, Inc.
Fort Worth, TX, US - Received
- January 29, 1990
- Decision date
- May 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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 |
| K250815 | Hubly Drill (H100)HBE · Traditional | Hubly, Inc. | 11/06/2025SE |
| K252060 | GreenHBE · Traditional | Phasor Health, LLC | 10/31/2025SE |
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| 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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| K972289 | Midas Rex MotorHBB · Traditional | 09/12/1997SE |
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| K962483 | Midas Rex III MotorHBB · Traditional | 11/19/1996SE |
| K953434 | Midas Rex Motors, (Midas I, Midas II & Convertible Models)HBB · Traditional | 05/16/1996SE |
| K954076 | Midas Rex Drill Attachments & Twist DrillsGET · Traditional | 10/18/1995SE |
| K953433 | Midas Rex Telescoping SystemGET · Traditional | 09/15/1995SE |
| K953432 | Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting ToolsGET · Traditional | 09/14/1995SE |
| K952463 | GS & GS20 Surgical Tool SystemGET · Traditional | 07/17/1995SE |
| K952300 | Midas Rex Motors (Midas I, II & Convertible Models)GET · Traditional | 05/26/1995SE |
| K854462 | Midas Rex Surgical Rubber Dam · Traditional | 11/22/1985SE |
Questions and answers
When was Modified Sterilization of Drills, Burrs, Trephines cleared by the FDA?
Modified Sterilization of Drills, Burrs, Trephines (K900388) received a 510(k) decision of Substantially Equivalent on May 7, 1990, 98 days after the submission was received.
What is the product code of K900388?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.