510(k) K202065
K202065 is an FDA 510(k) premarket notification submitted by Astura Medical, LLC for the device "DOLOMITE Anterior Cervical Stabilization System". The FDA issued a decision of Substantially Equivalent on October 26, 2020. The device falls under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical), a Class II device regulated under 21 CFR 888.3080. Astura Medical, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2020
- Date Received
- July 27, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.