510(k) K190363
K190363 is an FDA 510(k) premarket notification submitted by Omnia Medical, LLC for the device "Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage". The FDA issued a decision of Substantially Equivalent on February 21, 2020. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Omnia Medical, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2020
- Date Received
- February 15, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.