510(k) K192744
K192744 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "CORRIDOR Fixation System". The FDA issued a decision of Substantially Equivalent on Dec 16, 2019. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Globus Medical, Inc. has 173 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 16, 2019
- Date Received
- Sep 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Facet Screw Spinal Device
- Device Class
- Class U
- Review Panel
- OR
- Submission Type
- 510(k)