510(k) K231808
K231808 is an FDA 510(k) premarket notification submitted by GS Medical Co., Ltd. for the device "QUASAR Standalone ACIF System". The FDA issued a decision of Substantially Equivalent on July 20, 2023. The device falls under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical), a Class II device regulated under 21 CFR 888.3080. GS Medical Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2023
- Date Received
- June 20, 2023
- Clearance Type
- Special
- 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.