Lorenz Resorbable Distraction System or Expander
FDA 510(k) K030425 · Walter Lorenz Surgical, Inc.
510(k) numberK030425
Submission
- Device name
- Lorenz Resorbable Distraction System or Expander
- Applicant
- Walter Lorenz Surgical, Inc.
Jacksonville, FL, US - Received
- February 10, 2003
- Decision date
- May 14, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K040983 | Lorenz Self-Drilling Imf ScrewDZE · Special | 05/05/2004SE |
| K033740 | Lorenz Sternal Closure SystemHWC · Special | 12/15/2003SE |
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Questions and answers
When was Lorenz Resorbable Distraction System or Expander cleared by the FDA?
Lorenz Resorbable Distraction System or Expander (K030425) received a 510(k) decision of Substantially Equivalent on May 14, 2004, 459 days after the submission was received.
What is the product code of K030425?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.