Twist Drill
FDA 510(k) K062842 · Walter Lorenz Surgical, Inc.
510(k) numberK062842
Submission
- Device name
- Twist Drill
- Applicant
- Walter Lorenz Surgical, Inc.
Jacksonville, FL, US - Received
- September 22, 2006
- Decision date
- December 4, 2006
- 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 |
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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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| K063506 | Lorenz Sternal Closure SystemHRS · Special | 12/18/2006SE |
| K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumHRS · Special | 06/06/2006SE |
| K042516 | OtomimixNEA · Traditional | 11/08/2004SE |
| K030425 | Lorenz Resorbable Distraction System or ExpanderJEY · Traditional | 05/14/2004SE |
| K040990 | Modification to Self-Drilling Radiographic MarkersNEU · Special | 05/13/2004SE |
| K040983 | Lorenz Self-Drilling Imf ScrewDZE · Special | 05/05/2004SE |
| K033740 | Lorenz Sternal Closure SystemHWC · Special | 12/15/2003SE |
| K032228 | Lorenz 2.4 Self Drilling ScrewsHWC · Special | 08/11/2003SE |
Questions and answers
When was Twist Drill cleared by the FDA?
Twist Drill (K062842) received a 510(k) decision of Substantially Equivalent on December 4, 2006, 73 days after the submission was received.
What is the product code of K062842?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.