Nuvasive Percutaneous Transfacet/Intrapedicular Screw
FDA 510(k) K001323 · Nuvasive, Inc.
510(k) numberK001323
Submission
- Device name
- Nuvasive Percutaneous Transfacet/Intrapedicular Screw
- Applicant
- Nuvasive, Inc.
San Diego, CA, US - Received
- April 26, 2000
- Decision date
- July 25, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Nuvasive Percutaneous Transfacet/Intrapedicular Screw cleared by the FDA?
Nuvasive Percutaneous Transfacet/Intrapedicular Screw (K001323) received a 510(k) decision of Substantially Equivalent on July 25, 2000, 90 days after the submission was received.
What is the product code of K001323?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.