CORRIDOR Fixation System
FDA 510(k) K192744 · Globus Medical, Inc.
510(k) numberK192744
Submission
- Device name
- CORRIDOR Fixation System
- Applicant
- Globus Medical, Inc.
Audubon, PA, US - Received
- September 30, 2019
- Decision date
- December 16, 2019
- 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 CORRIDOR Fixation System cleared by the FDA?
CORRIDOR Fixation System (K192744) received a 510(k) decision of Substantially Equivalent on December 16, 2019, 77 days after the submission was received.
What is the product code of K192744?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.