510(k) K180728
K180728 is an FDA 510(k) premarket notification submitted by Spinal Elements, Inc. for the device "Spinal Elements Cerclage System". The FDA issued a decision of Substantially Equivalent on September 6, 2018. The device falls under product code OWI (Bone Fixation Cerclage, Sublaminar), a Class II device regulated under 21 CFR 888.3010. Spinal Elements, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2018
- Date Received
- March 20, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Fixation Cerclage, Sublaminar
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type
Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.