Modification to Townley Transfacetpedicular Screw Fixation System
FDA 510(k) K013829 · Medtronic Sofamor Danek, Inc.
510(k) numberK013829
Submission
- Device name
- Modification to Townley Transfacetpedicular Screw Fixation System
- Applicant
- Medtronic Sofamor Danek, Inc.
Memphis, TN, US - Received
- November 19, 2001
- Decision date
- December 19, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRW – System, Facet Screw Spinal Device
- Device class
- Unclassified
- Implant
- Yes
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Questions and answers
When was Modification to Townley Transfacetpedicular Screw Fixation System cleared by the FDA?
Modification to Townley Transfacetpedicular Screw Fixation System (K013829) received a 510(k) decision of Substantially Equivalent on December 19, 2001, 30 days after the submission was received.
What is the product code of K013829?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.