Self-Drilling Radiographic Marker
FDA 510(k) K014148 · Walter Lorenz Surgical, Inc.
510(k) numberK014148
Submission
- Device name
- Self-Drilling Radiographic Marker
- Applicant
- Walter Lorenz Surgical, Inc.
Jacksonville, FL, US - Received
- December 18, 2001
- Decision date
- January 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| 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 |
| K040983 | Lorenz Self-Drilling Imf ScrewDZE · Special | 05/05/2004SE |
| K033740 | Lorenz Sternal Closure SystemHWC · Special | 12/15/2003SE |
Questions and answers
When was Self-Drilling Radiographic Marker cleared by the FDA?
Self-Drilling Radiographic Marker (K014148) received a 510(k) decision of Substantially Equivalent on January 17, 2002, 30 days after the submission was received.
What is the product code of K014148?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.