510(k) K191835
K191835 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments". The FDA issued a decision of Substantially Equivalent on Aug 6, 2019. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Globus Medical, Inc. has 173 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 6, 2019
- Date Received
- Jul 9, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thoracolumbosacral Pedicle Screw System
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.