510(k) K190895
K190895 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System". The FDA issued a decision of Substantially Equivalent on Jul 18, 2019. The device falls under product code NKG (Posterior Cervical Screw System), a Class II device regulated under 21 CFR 888.3075. Medos International SARL has 95 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 18, 2019
- Date Received
- Apr 5, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Posterior Cervical Screw System
- Device Class
- Class II
- Regulation Number
- 888.3075
- Review Panel
- OR
- Submission Type
- 510(k)
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.