Lorenz Self-Drilling Imf Screw
FDA 510(k) K040983 · Walter Lorenz Surgical, Inc.
510(k) numberK040983
Submission
- Device name
- Lorenz Self-Drilling Imf Screw
- Applicant
- Walter Lorenz Surgical, Inc.
Jacksonville, FL, US - Received
- April 15, 2004
- Decision date
- May 5, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Decision |
|---|---|---|
| K063386 | Lorenz Orthodontic Anchorage SystemOAT · Traditional | 02/09/2007SE |
| K063052 | Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesJEY · Traditional | 01/12/2007SE |
| K063506 | Lorenz Sternal Closure SystemHRS · Special | 12/18/2006SE |
| K062842 | Twist DrillHBE · Traditional | 12/04/2006SE |
| 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 |
| 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 Lorenz Self-Drilling Imf Screw cleared by the FDA?
Lorenz Self-Drilling Imf Screw (K040983) received a 510(k) decision of Substantially Equivalent on May 5, 2004, 20 days after the submission was received.
What is the product code of K040983?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.