510(k) K221307
K221307 is an FDA 510(k) premarket notification submitted by Spinal Simplicity, LLC for the device "Edge Upper Cervical System". The FDA issued a decision of Substantially Equivalent on July 10, 2023. The device falls under product code NKG (Posterior Cervical Screw System), a Class II device regulated under 21 CFR 888.3075. Spinal Simplicity, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2023
- Date Received
- May 5, 2022
- 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
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.