2.1 x 255mm Drill, 22mm Stop
FDA 510(k) K223199 · Biomet Microfixation
510(k) numberK223199
Submission
- Device name
- 2.1 x 255mm Drill, 22mm Stop
- Applicant
- Biomet Microfixation
Jacksonville, FL, US - Received
- October 13, 2022
- Decision date
- November 15, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HBE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K213072 | 2.1 x 255mm Drill, 22mm StopHBE · Traditional | Biomet Micofixation | 08/23/2022SE |
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| K212782 | SternaLock Sternal Closure SystemHRS · Traditional | 05/17/2022SE |
| K212608 | RibFix Blu Thoracic Fixation SystemHRS · Traditional | 04/22/2022SE |
| K213712 | Pectus Support Bar SystemHRS · Traditional | 03/11/2022SE |
| K213208 | Twist DrillsHBE · Traditional | 12/23/2021SE |
| K202969 | Biomet Microfixation OmniMax MMF SystemJEY · Traditional | 08/05/2021SE |
| K190576 | WalterLorenz Surgical Assist Arm Scope HolderOCV · Traditional | 06/05/2019SE |
| K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation SystemHRS · Special | 12/09/2016SE |
| K163007 | Biomet Microfixation SternaLock 360 Sternal Closure SystemHRS · Special | 11/23/2016SE |
Questions and answers
When was 2.1 x 255mm Drill, 22mm Stop cleared by the FDA?
2.1 x 255mm Drill, 22mm Stop (K223199) received a 510(k) decision of Substantially Equivalent on November 15, 2022, 33 days after the submission was received.
What is the product code of K223199?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.